Multi Vessel Coronary Artery Disease, STEMI
Conditions
Keywords
STEMI, IMR, FFR, microcirculatory
Brief summary
The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients. Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the study.
Detailed description
Prospective, multicentre study designed to evaluate IMR ability to predict events occurrence, defined as Cardiovascular death, re-MI, re-hospitalization for HF, resuscitation or ICD appropriate shock, during a 1 year follow-up period. All participants will have the culprit lesion treated following clinical practice and guidelines; Fractional Flow Reserve (FFR) and IMR will be measured after the primary PCI procedure to evaluate treatment success and myocardial viability. Non-culprit lesions will be functionally evaluated through FFR index and will be treated if FFR will show functional stenosis. FFR and IMR will be measured to evaluate treatment success and myocardial viability. Patients will be followed-up at 1m, 6m and 1y periods.
Interventions
DEVICEPressureWire Certus guidewire
Assessment of IMR index in coronaries through PressureWire Certus guidewire
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient of legal age in hosting country able and willing to provide informed consent form 2. Hospital admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia 3. Electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous ECG leads, or with a left bundle-branch block (LBBB) 4. Multivessel diseased patients with lesions in the proximal 2/3 part of the vessels 5. Culprit Lesion EyeBall (EB) identified during evaluation of basal angiography 6. Presence of at least one non-culprit lesion \>50% EB detected in the basal angiography and eligible for PCI for which the operators decision is to perform a staged pre-discharge angioplasty procedure
Exclusion criteria
1. Patients who cannot give informed consent 2. A life expectancy of less than 1 year 3. Patients who are pregnant or nursing 4. Contra-indication to angiography 5. Allergy/intolerance to Adenosine 6. Contra-indication/Allergy/Intolerance to contrast media or to medical therapy foreseen for PCI 7. Documented allergy to Adenosine diphosphate (ADP) inhibitors (aspirin and clopidogrel) 8. New infarct on the same area of a previous infarct 9. Critical non treatable Lesion EB\>70% downstream of the culprit lesion 10. Absence of non-culprit lesion/s 11. Patient with hemodynamic instability not controllable with medical therapy and/or need intra aortic balloon pump implantation (IABP) 12. Prior Coronary Artery Bypass Graft (CABG) or indication for CABG 13. Patients with Left Main (LM) coronary artery disease requiring revascularization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock. | 1 year | Composite of: cardiovascular death\*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year. \* = timing of mortality evaluation: once culprit lesion has been evaluated through IMR Composite endpoint was evaluated as time to first event, whichever individual component occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular (LV) Remodeling | 1 year | Left Ventricular (LV) remodeling at 1 year; improvement of Ejection Fraction %(EF) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. |
| Left Ventricular (LV) Remodeling - Mitral Insufficiency | 1 year | Left Ventricular (LV) remodeling at 1 year; improvement of mitral insufficiency (MI) values assessed by TTE. A TTE evalutation has been done both at discharge and at 1-year fup. Each row reports the number of participants that have that specific grade of mitral insufficiency. Grade = 0 indicates no MI; grade = 1 indicates mild MI; grade = 2 indicates moderate MI; grade = 3 indicates severe MI |
| Need for New Revascularization | 1 year | Incidence of new revascularizations at 1 year |
| New Congestive Heart Failure (CHF) During Index Hospitalization | At the end of hospital stay | Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days |
| Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | 1 year | Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve. |
| Evaluation of Possible Events Predictors | 1 year | Results of logistic regression model; differences were considered statistically significant when p\<0,05. |
| Stent Thrombosis | 1 year | Incidence of stent thrombosis at 1 year |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IMR Evaluation Assessment of IMR index in coronaries through PressureWire Certus guidewire
PressureWire Certus guidewire: Assessment of IMR index in coronaries through PressureWire Certus guidewire | 242 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Withdrawal by subject or investigator | 16 |
Baseline characteristics
| Characteristic | IMR Evaluation | — |
|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 9.9 | — |
| Diastolic Blood Pressure | 78.6 mmHg STANDARD_DEVIATION 13.8 | — |
| Heart Rate | 74.5 bpm (Beats Per Minute) STANDARD_DEVIATION 15.8 | — |
| Height | 169.6 cm STANDARD_DEVIATION 6.9 | — |
| Infarcted area Circumflex Artery (CX) | 38 Participants | — |
| Infarcted area Left Anterior Descending (LAD) coronary artery | 104 Participants | — |
| Infarcted area Right Coronary Artery (RCA) | 100 Participants | — |
| Killip class Class I | 230 Participants | — |
| Killip class Class II | 12 Participants | — |
| Killip class Class III | 0 Participants | — |
| Killip class Class IV | 0 Participants | — |
| Parrticipants with Hyperlipidemia and/or Dyslipidemia | 105 Participants | — |
| Participants with Diabetes Diet | 5 Participants | — |
| Participants with Diabetes Insulin | 7 Participants | — |
| Participants with Diabetes None | 205 Participants | — |
| Participants with Diabetes Oral treatment | 25 Participants | — |
| Participants with Family history of heart disease | 67 Participants | — |
| Participants with history of Heart failure | 3 Participants | — |
| Participants with history of Myocardial Infarction | 7 Participants | — |
| Participants with history of Percutaneous Coronary Intervention (PCI) | 13 Participants | — |
| Participants with history of stroke | 3 Participants | — |
| Participants with history of Transient Ischemic Attach (TIA) | 5 Participants | — |
| Participants with Hypertension | 116 Participants | — |
| Participants with Renal dysfunction None | 239 Participants | — |
| Participants with Renal dysfunction With dialysis | 0 Participants | — |
| Participants with Renal dysfunction Without dialysis | 3 Participants | — |
| Participants with significant alcohol intake | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 35 Participants | — |
| Sex: Female, Male Male | 207 Participants | — |
| Smoker Current | 100 Participants | — |
| Smoker Ex smoker | 31 Participants | — |
| Smoker None | 111 Participants | — |
| Syntax Score (SS) | 16.3 units on a scale STANDARD_DEVIATION 5.8 | — |
| Systolic Blood Pressure | 133.5 mmHg STANDARD_DEVIATION 24.8 | — |
| Weight | 77 kg STANDARD_DEVIATION 11.8 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 242 |
| other Total, other adverse events | 16 / 242 |
| serious Total, serious adverse events | 58 / 242 |
Outcome results
Primary
Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock.
Composite of: cardiovascular death\*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year. \* = timing of mortality evaluation: once culprit lesion has been evaluated through IMR Composite endpoint was evaluated as time to first event, whichever individual component occurred first.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI Patient | Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock. | 8 Participants |
Secondary
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events
Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve.
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 95 | 0.125 probability |
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 65 | 0.375 probability |
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 55 | 0.5 probability |
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 48 | 0.625 probability |
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 34.5 | 0.75 probability |
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 32 | 0.875 probability |
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 30 | 0.875 probability |
| STEMI Patient | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 20 | 0.875 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 55 | 0.281 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 30 | 0.57 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 48 | 0.325 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 34.5 | 0.491 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 32 | 0.531 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 95 | 0.114 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 65 | 0.211 probability |
| STEMI Pat. at 1 Y Fup | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 20 | 0.768 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 55 | 0.610 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 65 | 0.582 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 95 | 0.505 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 48 | 0.650 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 30 | 0.652 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 32 | 0.672 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 34.5 | 0.629 probability |
| Area Under the Curve | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | IMR cut-off value = 20 | 0.554 probability |
Secondary
Evaluation of Possible Events Predictors
Results of logistic regression model; differences were considered statistically significant when p\<0,05.
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| STEMI Patient | Evaluation of Possible Events Predictors | Age | 0,3139 correlation coefficient |
| STEMI Patient | Evaluation of Possible Events Predictors | Male | 0,8407 correlation coefficient |
| STEMI Patient | Evaluation of Possible Events Predictors | Number of PCIs (PCIs done both during Primary and Staged procedures) | 0,0415 correlation coefficient |
| STEMI Patient | Evaluation of Possible Events Predictors | Hypertension | 0,3039 correlation coefficient |
| STEMI Patient | Evaluation of Possible Events Predictors | Lipids | 0,1948 correlation coefficient |
| STEMI Patient | Evaluation of Possible Events Predictors | Smoking | 0,5603 correlation coefficient |
| STEMI Patient | Evaluation of Possible Events Predictors | LVEF (at discharge) | 0,0320 correlation coefficient |
| STEMI Patient | Evaluation of Possible Events Predictors | WMSI (at discharge) | 0,2320 correlation coefficient |
Secondary
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Ejection Fraction %(EF) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.
Time frame: 1 year
Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STEMI Patient | Left Ventricular (LV) Remodeling | 53.3 % of ejection fraction | Standard Deviation 8.6 |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling | 56.2 % of ejection fraction | Standard Deviation 7.9 |
Secondary
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Diastole Diameter (LVEDD) and Left Ventricular End Systole Diameter (LVESD) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.
Time frame: 1 year
Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEMI Patient | Left Ventricular (LV) Remodeling | LVEDD (mm) | 51.4 mm | Standard Deviation 29.7 |
| STEMI Patient | Left Ventricular (LV) Remodeling | LVESD (mm) | 35.5 mm | Standard Deviation 8.5 |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling | LVEDD (mm) | 50.2 mm | Standard Deviation 7.5 |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling | LVESD (mm) | 33.9 mm | Standard Deviation 6.6 |
Secondary
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of 16 segments Wall Motion Score Index (WMSI) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. 16WMSI = 1 is considered normokinetic; 16WMSI = 1,5 is considered mild hypokinesia; 16WMSI = 2 is considered hypokinesia; 16WMSI = 2,5 is considered severe hypokinesia; 16WMSI = 3 is considered akinetic. Scale range: from 1 to 3
Time frame: 1 year
Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STEMI Patient | Left Ventricular (LV) Remodeling | 1.8 index | Standard Deviation 2.9 |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling | 1.9 index | Standard Deviation 3.9 |
Secondary
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Systole Volume (LVESV) and Left Ventricular End Diastole Volume (LVEDV) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.
Time frame: 1 year
Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEMI Patient | Left Ventricular (LV) Remodeling | LVESV (ml) | 50.6 ml | Standard Deviation 21.8 |
| STEMI Patient | Left Ventricular (LV) Remodeling | LVEDV (ml) | 101.7 ml | Standard Deviation 28.5 |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling | LVESV (ml) | 47.4 ml | Standard Deviation 20.3 |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling | LVEDV (ml) | 102.3 ml | Standard Deviation 32.4 |
Secondary
Left Ventricular (LV) Remodeling - Mitral Insufficiency
Left Ventricular (LV) remodeling at 1 year; improvement of mitral insufficiency (MI) values assessed by TTE. A TTE evalutation has been done both at discharge and at 1-year fup. Each row reports the number of participants that have that specific grade of mitral insufficiency. Grade = 0 indicates no MI; grade = 1 indicates mild MI; grade = 2 indicates moderate MI; grade = 3 indicates severe MI
Time frame: 1 year
Population: Echo data site reported, a complete echo has not been always done during discharge and fup visits
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STEMI Patient | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 0 | 35 Participants |
| STEMI Patient | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 1 | 130 Participants |
| STEMI Patient | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 2 | 29 Participants |
| STEMI Patient | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 3 | 5 Participants |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 3 | 1 Participants |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 0 | 33 Participants |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 2 | 26 Participants |
| STEMI Pat. at 1 Y Fup | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Grade 1 | 139 Participants |
Secondary
Need for New Revascularization
Incidence of new revascularizations at 1 year
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI Patient | Need for New Revascularization | 12 Participants |
Secondary
New Congestive Heart Failure (CHF) During Index Hospitalization
Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days
Time frame: At the end of hospital stay
Population: Participants that had a new congestive heart failure (CHF) during index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI Patient | New Congestive Heart Failure (CHF) During Index Hospitalization | 8 Participants |
Secondary
Stent Thrombosis
Incidence of stent thrombosis at 1 year
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI Patient | Stent Thrombosis | 1 Participants |