Status:
UNKNOWN
Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
30-80 years
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). Th...
Eligibility Criteria
Inclusion
- Subject Inclusion Criteria
- Patients need to meet all the following inclusion criteria to be enrolled in the study:
- Symptomatic and hemodynamically stable
- Acute coronary syndrome (ACS) ruled out based on absence of abnormal changes in ECG and cardiac enzymes
- 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.
- Ability to undergo stress myocardial perfusion test (absence of contraindications for vasodilator)
- Written informed consent
- Subject Exclusion Criteria
- Patients meeting at least one of the following criteria will be excluded from the study:
- Recent (\< 1 month) ACS
- CCTA reveals ≥ 50% stenosis in the left main artery
- Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
- 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.
- History of CABG surgery
- History of malignancy during the past 3 years prior to screening
- History of alcohol and/or drug abuse within 3 years prior to screening
- Sign of pregnancy
- Pregnant or nursing
- History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents
- Recent (\< 1 month) use of an investigational drug or device
- Participation in any other investigational drug or device trial during the conduct of this study
- Lack of ability or willingness to comply with the protocol requirements or deemed by the Site Investigator to be unfit for the study
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04712513
Start Date
March 1 2021
End Date
March 1 2024
Last Update
January 15 2021
Active Locations (1)
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1
St Joseph's Hospital
London, Ontario, Canada, N6A 4V2