Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

NCT ID: NCT04712513

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2024-03-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with coronary artery disease and hemodynamically stable

Dynamic cardiac CT perfusion imaging

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Dynamic 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Aaron So

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St Joseph's Hospital

London, Ontario, Canada

Countries

Canada

Central Contacts

Aaron So, PhD

Role: CONTACT

aso@robarts.ca

(519)9315777 ext. 24224

Facility Contacts

Aaron So, PhD

Role: primary

aso@robarts.ca

(519)9315777 ext. 24224

Other Identifiers

12052020

Identifier Type: -

Identifier Source: org_study_id