Atherosclerosis, Coronary, Heart Disease, Ischemic
Conditions
Keywords
Myocardial Perfusion Imaging, Magnetic Resonance Imaging
Brief summary
The purpose of the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the reference standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.
Detailed description
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35. With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a one stop shop for cardiac Magnetic Resonance Imaging.
Interventions
DRUGGadolinium
DRUGAdenosine
Sponsors
Astellas Pharma US, Inc.
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Northwestern University
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
Under an Institutional Committee on Human Research board approved protocol 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be recruited in this prospective study. Volunteers will be recruited for the purpose of protocol development and will not be included in analysis. All subjects will be screened for glomerular filtration rate (GFR) within 24 hours before the exam. All patients must have a GFR \> 30 mL/min/1.73m2 to be part of the study. All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of \< 30 mL/min will not be selected for the study to avoid NSF. Patients with GFR \< 60 ml/min but \>30 ml/min will receive a reduced dose of Gadolinium contrast (0.1 ml/kg).
Exclusion criteria
1. Age \<18 years; 2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc); 3. Claustrophobia; 4. Inability to perform an adequate breath-hold for imaging, 5. Inability to provide informed consent; 6. all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR \< 30 ml/min will be excluded; 7. Pregnant and lactating women; 8. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin; 9. Contra indication for Adenosine 1. 2nd- or 3rd-degree atrioventricular block (except in patients with a functioning artificial pacemaker) 2. Sinus node disease (except in patients with a functioning artificial pacemaker) 3. Unstable angina 4. Acute myocardial infarction 5. Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) 6. Hypersensitivity to adenosine 7. Caffeine within 12-24 hours 8. Theophylline and Dipyridamole products within 24 hours. 10. Contra indication for Metoprolol 1. sinus bradycardia 2. heart block greater than first degree 3. Cardiac Failure 4. Bronchospastic Disease 11. Contra indication for Nitroglycerin 1. Early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin. b .Administration of Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnetic Resonance Image Quality Rating | Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods. | The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol | 14 days | Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adenosine Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.
adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Adenosine |
|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 8.21 |
| Body Mass Index (BMI) | 29.57 kg/m^2 STANDARD_DEVIATION 5.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Magnetic Resonance Image Quality Rating
The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality
Time frame: Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ischemic Heart Disease Patients | Magnetic Resonance Image Quality Rating | Motion Corrected Images | 3.57 units on a likert scale | Standard Deviation 0.66 |
| Ischemic Heart Disease Patients | Magnetic Resonance Image Quality Rating | Non-Corrected Breath-Hold, Shallow-Breathing Image | 2.55 units on a likert scale | Standard Deviation 0.81 |
Comparison: The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image qualityp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol
Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ischemic Heart Disease Patients | Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol | 0 occurances of adverse events |