Coronary Artery Disease
Conditions
Keywords
Computed Tomography, Myocardial Perfusion, Fractional Flow Reserve
Brief summary
The objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). The proposed CTP technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (FFR) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with CAD. The CTP results will be compared with invasive coronary angiography / FFR assessment and non-invasive cardiac magnetic resonance imaging (CMR) / radionuclide perfusion assessment.
Interventions
DIAGNOSTIC_TESTDynamic cardiac CT perfusion imaging
Multiple images of the heart are acquired with a clinical CT scanner after an intravenous bolus injection of contrast solution. The images are then analyzed to provide fractional flow reserve and myocardial perfusion values.
Sponsors
Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject Inclusion Criteria Patients need to meet all the following inclusion criteria to be enrolled in the study: 1. Symptomatic and hemodynamically stable 2. Acute coronary syndrome (ACS) ruled out based on absence of abnormal changes in ECG and cardiac enzymes 3. Referral for cardiac catheterization based on clinical history and non-invasive imaging test findings. Non-invasive imaging findings include one or more of the following: (i) Evidence of myocardial ischemia from radionuclide myocardial perfusion imaging; (ii) Evidence of myocardial ischemia from CMR myocardial perfusion imaging; (iii) Evidence of ≥ 50% stenosis in the left circumflex artery (LCx), left anterior descending artery (LAD) and/or right coronary artery (RCA) from CCTA. 4. Ability to undergo stress myocardial perfusion test (absence of contraindications for vasodilator) 5. Written informed consent 2. Subject
Exclusion criteria
Patients meeting at least one of the following criteria will be excluded from the study: 1. Recent (\< 1 month) ACS 2. CCTA reveals ≥ 50% stenosis in the left main artery 3. Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 4. Contraindications to stress perfusion imaging, including: i) severe reactive airway disease; ii) high-grade atrioventricular block; iii) allergy to vasodilators; iv) caffeine within 12 hours; v) theophylline use within 48 hours. 5. History of CABG surgery 6. History of malignancy during the past 3 years prior to screening 7. History of alcohol and/or drug abuse within 3 years prior to screening 8. Sign of pregnancy 9. Pregnant or nursing 10. History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents 11. Recent (\< 1 month) use of an investigational drug or device 12. Participation in any other investigational drug or device trial during the conduct of this study 13. Lack of ability or willingness to comply with the protocol requirements or deemed by the Site Investigator to be unfit for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of FFR obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis | Within 4 weeks prior to invasive cardiac catheterization | Comparison with invasive coronary angiography and FFR assessment |
| Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and static CT perfusion | Within 4 weeks prior to invasive cardiac catheterization | Comparison in patients with multi-vessel CAD where balanced ischemia is expected |
| Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and CT-FFR (based on computational fluid dynamics simulation) | Within 4 weeks prior to invasive cardiac catheterization | Comparison in patients with dense coronary calcification |
| Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis | Within 4 weeks prior to invasive cardiac catheterization | Comparison with invasive coronary angiography and FFR assessment |
| Accuracy of combined myocardial perfusion and FFR measurement obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis | Within 4 weeks prior to invasive cardiac catheterization | Comparison with invasive coronary angiography and FFR assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of diagnostic accuracy of dynamic CT perfusion for functional CAD assessment between male and female patients | Within 4 weeks prior to invasive cardiac catheterization | Sex-based analysis |
| Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques | Within 4 weeks of the acquisition of non-CT perfusion imaging | Comparison with CMR / radionuclide perfusion assessment |
Countries
Canada
Contacts
Primary ContactAaron So, PhD
Outcome results
None listed