Ischemic Cardiomyopathy
Conditions
Keywords
Autologous, Cardiac, Stem Cell, Transplant
Brief summary
This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow up visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.
Detailed description
This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease is safe, can promote neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study will be to evaluate the safety of autologous-bone-marrow mononuclear cell injections. The secondary endpoint of the study is to assess the efficacy of autologous bone marrow cells in improving cardiac contractile function and functional outcome. The efficacy will be assessed on the basis of the treadmill Max VO2 (maximum volume oxygen uptake). Secondarily the efficacy will be assessed on the basis of clinical status and imaging rests, with follow-up extending to 1 year after enrollment.A maximum of 30 patients will be enrolled in the study. At the end of the 6-month visit. after the required angiogram with mapping and non-invasive testing is complete, the patients will be told whether they were in the control or the active group (stem cell therapy). Those in the control group will be told before final invasive testing, and those who consent may cross over to the active therapy arm and undergo the cell injection procedure (control, then stem cell therapy. In these patients, the foll-up angiogram and mapping procedure will also serve as the baseline procedure required for cell injection. Bone marrow mononuclear cells will be injected in an identical fashion, according to the same criteria described for the original treatment group, and these patients will have identical follow-up visits starting again at the baseline time-point and extending for up to 1 year.
Interventions
DEVICEIntramyocardial Injection of stem cells via NOGA Mapping
Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.
OTHERControl, then Stem Cell Therapy
Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.
Sponsors
CHI St. Luke's Health, Texas
Texas Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* LVEF less than 45% * Functional class III or IV angina * At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study * there are additional inc. criteria
Exclusion criteria
* AGe \<18 or \>70 years of age * Constant atrial fibrillation * Left ventricular (LV) thrombus * History of malignancy in the last 5 years * LV wall thickness of \< 8 mm at the target site * there are additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Autologous-bone-marrow Injections | up to 2 weeks post-procedure, 3 months and 6 months | Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF \[CHF\], acute coronary syndrome, myocardial infarction, stroke, or death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New York Heart Association (NYHA)Classification | baseline, 3 months and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity. Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound) |
| Myocardial Oxygen Consumption (MVO2) | baseline, 3 months and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute. |
| Echocardiography (EF)Percent (%) | baseline, 3 months and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction. |
| Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) | baseline and 3 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25. |
| Echocardiography Wall Motion Score Index (WMSI) | baseline and 3 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments. |
| Canadian Cardiovascular (CCS) Angina Score | baseline, 3 months and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain). Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation) |
| Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) | baseline and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the gold standard. |
| Left Ventricular End-Diastolic Volume (LVEDV) | baseline, 3 months and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters. |
| Left Ventricular End-Systolic Volume (LVESV) (ml) | baseline, 3 months and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters. |
| Endocardial Unipolar Voltages (UPV) | baseline and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is \<5.5 mV. |
| Linear Local Shortening (LLS) | baseline and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction. |
| Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | baseline, 3 months and 6 months | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction. |
Countries
United States
Participant flow
Recruitment details
Thirty patients were recruited between 4/14/04 and 2/8/07 from outpatient cardiology clinics.
Participants by arm
| Arm | Count |
|---|---|
| Control, Then Stem Cell Therapy Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.
At 6 months, subject is offered stem cell therapy. | 10 |
| Stem Cell Therapy Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. | 20 |
| Total | 30 |
Baseline characteristics
| Characteristic | Stem Cell Therapy | Control, Then Stem Cell Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 0 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 10 Participants | 24 Participants |
| Age, Continuous | 60.5 years STANDARD_DEVIATION 6.4 | 56.3 years STANDARD_DEVIATION 8.6 | 60.0 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 20 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 18 / 20 |
| serious Total, serious adverse events | 7 / 10 | 11 / 20 |
Outcome results
Primary
Safety of Autologous-bone-marrow Injections
Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF \[CHF\], acute coronary syndrome, myocardial infarction, stroke, or death).
Time frame: up to 2 weeks post-procedure, 3 months and 6 months
Population: Adverse events which occurred in all participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Death (6 months) | 0 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | post-procedural transient left bundle branch block | 1 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Post-procedure pericardial effusion (nonsignifiant | 0 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Post-procedure transient fever | 1 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Fever (6 months) | 2 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Sustained ventricular arrhythmias (6 months) | 0 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Discharge implantable cardiac defibrillator (6 mo) | 0 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Exacerbation of congestive heart failure (6 mo) | 1 participants |
| Control, Then Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Myocardial infarction (6 months) | 0 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Exacerbation of congestive heart failure (6 mo) | 2 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Sustained ventricular arrhythmias (6 months) | 0 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | post-procedural transient left bundle branch block | 1 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Death (6 months) | 0 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Post-procedure pericardial effusion (nonsignifiant | 1 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Discharge implantable cardiac defibrillator (6 mo) | 1 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Post-procedure transient fever | 0 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Myocardial infarction (6 months) | 0 participants |
| Stem Cell Therapy | Safety of Autologous-bone-marrow Injections | Fever (6 months) | 0 participants |
Secondary
Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the gold standard.
Time frame: baseline and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) | Angiography LVEF (%) baseline | 40 Angiography LVEF (%) | Standard Deviation 3.2 |
| Control, Then Stem Cell Therapy | Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) | Angiography LVEF (%) 6 months | 40.9 Angiography LVEF (%) | Standard Deviation 8.5 |
| Stem Cell Therapy | Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) | Angiography LVEF (%) baseline | 37.5 Angiography LVEF (%) | Standard Deviation 8.2 |
| Stem Cell Therapy | Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) | Angiography LVEF (%) 6 months | 42 Angiography LVEF (%) | Standard Deviation 14.4 |
Secondary
Canadian Cardiovascular (CCS) Angina Score
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain). Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)
Time frame: baseline, 3 months and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Canadian Cardiovascular (CCS) Angina Score | CCS baseline | 3 units on a scale | Standard Deviation 0.3 |
| Control, Then Stem Cell Therapy | Canadian Cardiovascular (CCS) Angina Score | CCS 3 months | 2.2 units on a scale | Standard Deviation 0.3 |
| Control, Then Stem Cell Therapy | Canadian Cardiovascular (CCS) Angina Score | CCS 6 months | 2.6 units on a scale | Standard Deviation 0.3 |
| Stem Cell Therapy | Canadian Cardiovascular (CCS) Angina Score | CCS baseline | 3 units on a scale | Standard Deviation 0.2 |
| Stem Cell Therapy | Canadian Cardiovascular (CCS) Angina Score | CCS 3 months | 2.1 units on a scale | Standard Deviation 0.2 |
| Stem Cell Therapy | Canadian Cardiovascular (CCS) Angina Score | CCS 6 months | 1.8 units on a scale | Standard Deviation 0.2 |
Secondary
Echocardiography (EF)Percent (%)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.
Time frame: baseline, 3 months and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Echocardiography (EF)Percent (%) | Echocardiography EF (%) baseline | 39 Ejection Fraction % | Standard Deviation 9.1 |
| Control, Then Stem Cell Therapy | Echocardiography (EF)Percent (%) | Echocardiography EF (%) 3 months | 41 Ejection Fraction % | Standard Deviation 5.4 |
| Control, Then Stem Cell Therapy | Echocardiography (EF)Percent (%) | Echocardiography EF (%) 6 months | 42 Ejection Fraction % | Standard Deviation 5.4 |
| Stem Cell Therapy | Echocardiography (EF)Percent (%) | Echocardiography EF (%) baseline | 37 Ejection Fraction % | Standard Deviation 10.6 |
| Stem Cell Therapy | Echocardiography (EF)Percent (%) | Echocardiography EF (%) 3 months | 38 Ejection Fraction % | Standard Deviation 5.4 |
| Stem Cell Therapy | Echocardiography (EF)Percent (%) | Echocardiography EF (%) 6 months | 40 Ejection Fraction % | Standard Deviation 5.4 |
Secondary
Echocardiography Wall Motion Score Index (WMSI)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.
Time frame: baseline and 3 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Echocardiography Wall Motion Score Index (WMSI) | Wall Motion Score Index (WMSI) baseline | 1.7 Wall Motion Score Index | Standard Deviation 0.5 |
| Control, Then Stem Cell Therapy | Echocardiography Wall Motion Score Index (WMSI) | Wall Motion Score Index (WMSI) 3 months | 1.6 Wall Motion Score Index | Standard Deviation 0.4 |
| Stem Cell Therapy | Echocardiography Wall Motion Score Index (WMSI) | Wall Motion Score Index (WMSI) baseline | 1.7 Wall Motion Score Index | Standard Deviation 0.5 |
| Stem Cell Therapy | Echocardiography Wall Motion Score Index (WMSI) | Wall Motion Score Index (WMSI) 3 months | 1.7 Wall Motion Score Index | Standard Deviation 0.6 |
Secondary
Endocardial Unipolar Voltages (UPV)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is \<5.5 mV.
Time frame: baseline and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Endocardial Unipolar Voltages (UPV) | UPV (mV) baseline | 10.2 Unipolar voltage (mV) | Standard Deviation 4.3 |
| Control, Then Stem Cell Therapy | Endocardial Unipolar Voltages (UPV) | UPV (mV) 6 months | 10.1 Unipolar voltage (mV) | Standard Deviation 4.8 |
| Stem Cell Therapy | Endocardial Unipolar Voltages (UPV) | UPV (mV) baseline | 10.5 Unipolar voltage (mV) | Standard Deviation 5.1 |
| Stem Cell Therapy | Endocardial Unipolar Voltages (UPV) | UPV (mV) 6 months | 10.8 Unipolar voltage (mV) | Standard Deviation 5.4 |
Secondary
Left Ventricular End-Diastolic Volume (LVEDV)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.
Time frame: baseline, 3 months and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Left Ventricular End-Diastolic Volume (LVEDV) | LVEDV (ml) baseline | 132.2 Volume in left ventricle (milliliters) | Standard Deviation 43.6 |
| Control, Then Stem Cell Therapy | Left Ventricular End-Diastolic Volume (LVEDV) | LVEDV (ml) 3 months | 125.7 Volume in left ventricle (milliliters) | Standard Deviation 46.3 |
| Control, Then Stem Cell Therapy | Left Ventricular End-Diastolic Volume (LVEDV) | LVEDV (ml) 6 months | 120.0 Volume in left ventricle (milliliters) | Standard Deviation 30.9 |
| Stem Cell Therapy | Left Ventricular End-Diastolic Volume (LVEDV) | LVEDV (ml) baseline | 133.2 Volume in left ventricle (milliliters) | Standard Deviation 53.6 |
| Stem Cell Therapy | Left Ventricular End-Diastolic Volume (LVEDV) | LVEDV (ml) 3 months | 123.9 Volume in left ventricle (milliliters) | Standard Deviation 58.2 |
| Stem Cell Therapy | Left Ventricular End-Diastolic Volume (LVEDV) | LVEDV (ml) 6 months | 123.9 Volume in left ventricle (milliliters) | Standard Deviation 39.7 |
Secondary
Left Ventricular End-Systolic Volume (LVESV) (ml)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.
Time frame: baseline, 3 months and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Left Ventricular End-Systolic Volume (LVESV) (ml) | LVESV (ml) baseline | 81.7 ml | Standard Deviation 40.7 |
| Control, Then Stem Cell Therapy | Left Ventricular End-Systolic Volume (LVESV) (ml) | LVESV (ml) 3 months | 74.4 ml | Standard Deviation 37 |
| Control, Then Stem Cell Therapy | Left Ventricular End-Systolic Volume (LVESV) (ml) | LVESV (ml) 6 months | 71.8 ml | Standard Deviation 27.2 |
| Stem Cell Therapy | Left Ventricular End-Systolic Volume (LVESV) (ml) | LVESV (ml) baseline | 92.9 ml | Standard Deviation 50.5 |
| Stem Cell Therapy | Left Ventricular End-Systolic Volume (LVESV) (ml) | LVESV (ml) 3 months | 83.2 ml | Standard Deviation 43.2 |
| Stem Cell Therapy | Left Ventricular End-Systolic Volume (LVESV) (ml) | LVESV (ml) 6 months | 74 ml | Standard Deviation 29.5 |
Secondary
Linear Local Shortening (LLS)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.
Time frame: baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Linear Local Shortening (LLS) | LLS (%) baseline | 12.1 percentage of linear local shortening | Standard Deviation 6.8 |
| Control, Then Stem Cell Therapy | Linear Local Shortening (LLS) | LLS (%) 6 months | 9.1 percentage of linear local shortening | Standard Deviation 6.4 |
| Stem Cell Therapy | Linear Local Shortening (LLS) | LLS (%) baseline | 10.5 percentage of linear local shortening | Standard Deviation 7.3 |
| Stem Cell Therapy | Linear Local Shortening (LLS) | LLS (%) 6 months | 10.8 percentage of linear local shortening | Standard Deviation 6.8 |
Secondary
Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.
Time frame: baseline and 3 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) | VE/VCO2 baseline | 29.8 VE/VCO2 slope | Standard Deviation 8 |
| Control, Then Stem Cell Therapy | Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) | VE/VCO2 3 months | 32.8 VE/VCO2 slope | Standard Deviation 5 |
| Stem Cell Therapy | Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) | VE/VCO2 baseline | 32.7 VE/VCO2 slope | Standard Deviation 6 |
| Stem Cell Therapy | Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) | VE/VCO2 3 months | 31.8 VE/VCO2 slope | Standard Deviation 7 |
Secondary
Myocardial Oxygen Consumption (MVO2)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.
Time frame: baseline, 3 months and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Myocardial Oxygen Consumption (MVO2) | MVO2 (ml/kg per min) 6 months | 15.6 Percentage of Oxygen Saturation | Standard Deviation 0.9 |
| Control, Then Stem Cell Therapy | Myocardial Oxygen Consumption (MVO2) | MVO2 (ml/kg per min) baseline | 14.8 Percentage of Oxygen Saturation | Standard Deviation 0.8 |
| Control, Then Stem Cell Therapy | Myocardial Oxygen Consumption (MVO2) | MVO2 (ml/kg per min) 3 months | 15.7 Percentage of Oxygen Saturation | Standard Deviation 0.8 |
| Stem Cell Therapy | Myocardial Oxygen Consumption (MVO2) | MVO2 (ml/kg per min) baseline | 14.7 Percentage of Oxygen Saturation | Standard Deviation 0.6 |
| Stem Cell Therapy | Myocardial Oxygen Consumption (MVO2) | MVO2 (ml/kg per min) 3 months | 15.5 Percentage of Oxygen Saturation | Standard Deviation 0.6 |
| Stem Cell Therapy | Myocardial Oxygen Consumption (MVO2) | MVO2 (ml/kg per min) 6 months | 15.8 Percentage of Oxygen Saturation | Standard Deviation 0.6 |
Secondary
New York Heart Association (NYHA)Classification
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity. Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)
Time frame: baseline, 3 months and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | New York Heart Association (NYHA)Classification | NYHA Baseline | 2.6 NYHA Functional Class | Standard Deviation 0.3 |
| Control, Then Stem Cell Therapy | New York Heart Association (NYHA)Classification | NYHA 3 months | 1.9 NYHA Functional Class | Standard Deviation 0.3 |
| Control, Then Stem Cell Therapy | New York Heart Association (NYHA)Classification | NYHA 6 months | 2.4 NYHA Functional Class | Standard Deviation 0.3 |
| Stem Cell Therapy | New York Heart Association (NYHA)Classification | NYHA Baseline | 2.3 NYHA Functional Class | Standard Deviation 0.2 |
| Stem Cell Therapy | New York Heart Association (NYHA)Classification | NYHA 3 months | 2 NYHA Functional Class | Standard Deviation 0.2 |
| Stem Cell Therapy | New York Heart Association (NYHA)Classification | NYHA 6 months | 1.8 NYHA Functional Class | Standard Deviation 0.2 |
Secondary
Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%)
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.
Time frame: baseline, 3 months and 6 months
Population: The data was analyzed for all participants in control and treated groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control, Then Stem Cell Therapy | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | SPECT LVEF (%) baseline | 43 Left Ventricular Ejection Fraction (%) | Standard Deviation 10.4 |
| Control, Then Stem Cell Therapy | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | SPECT LVEF (%) 3 months | 46.8 Left Ventricular Ejection Fraction (%) | Standard Deviation 9.5 |
| Control, Then Stem Cell Therapy | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | SPECT LVEF (%) 6 months | 47.8 Left Ventricular Ejection Fraction (%) | Standard Deviation 7.5 |
| Stem Cell Therapy | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | SPECT LVEF (%) baseline | 41.5 Left Ventricular Ejection Fraction (%) | Standard Deviation 11.2 |
| Stem Cell Therapy | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | SPECT LVEF (%) 3 months | 43.2 Left Ventricular Ejection Fraction (%) | Standard Deviation 11.1 |
| Stem Cell Therapy | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | SPECT LVEF (%) 6 months | 44 Left Ventricular Ejection Fraction (%) | Standard Deviation 13.4 |