Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

• ClinicalTrials.gov Identifier: NCT04712513
• Recruitment Status: Unknown
• First Posted: January 15, 2021
• Last Update Posted: January 15, 2021
• Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); London Health Sciences Centre
• Information provided by (Responsible Party): Aaron So, Lawson Health Research Institute

Study Description

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.

Condition or disease	Intervention/treatment
Coronary Artery Disease	Diagnostic Test: Dynamic cardiac CT perfusion imaging

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 240 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Official Title: Multicenter Diagnostic Performance of Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease
• Estimated Study Start Date: March 2021
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patients with coronary artery disease and hemodynamically stable	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures :

1. Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis [ Time Frame: Within 4 weeks prior to invasive cardiac catheterization ]
   Comparison with invasive coronary angiography and FFR assessment
2. Accuracy of FFR obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis [ Time Frame: Within 4 weeks prior to invasive cardiac catheterization ]
   Comparison with invasive coronary angiography and FFR assessment
3. Accuracy of combined myocardial perfusion and FFR measurement obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis [ Time Frame: Within 4 weeks prior to invasive cardiac catheterization ]
   Comparison with invasive coronary angiography and FFR assessment
4. Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and static CT perfusion [ Time Frame: Within 4 weeks prior to invasive cardiac catheterization ]
   Comparison in patients with multi-vessel CAD where balanced ischemia is expected
5. Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and CT-FFR (based on computational fluid dynamics simulation) [ Time Frame: Within 4 weeks prior to invasive cardiac catheterization ]
   Comparison in patients with dense coronary calcification

Secondary Outcome Measures :

1. Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques [ Time Frame: Within 4 weeks of the acquisition of non-CT perfusion imaging ]
   Comparison with CMR / radionuclide perfusion assessment
2. Comparison of diagnostic accuracy of dynamic CT perfusion for functional CAD assessment between male and female patients [ Time Frame: Within 4 weeks prior to invasive cardiac catheterization ]
   Sex-based analysis

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients are those who have clinically indicated referral for cardiac catheterization based on clinical history and sign of ischemia or obstructive coronary lesion(s) from non-invasive imaging test (radionuclide myocardial perfusion imaging, CMR myocardial perfusion imaging, or CCTA).

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

Contacts and Locations

Contacts

Contact: Aaron So, PhD; (519)9315777 ext 24224; aso@robarts.ca

Locations

Canada, Ontario

St Joseph's Hospital

London, Ontario, Canada, N6A 4V2

Contact: Aaron So, PhD (519)9315777 ext 24224 aso@robarts.ca

Principal Investigator: Aaron So, PhD

Sub-Investigator: Patrick Teefy, MD

Sub-Investigator: Shahar Lavi, MD

Sponsors and Collaborators

Lawson Health Research Institute

Canadian Institutes of Health Research (CIHR)

London Health Sciences Centre

More Information

• Responsible Party: Aaron So, Scientist, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT04712513
• Other Study ID Numbers: 12052020
• First Posted: January 15, 2021
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Aaron So, Lawson Health Research Institute:

Computed Tomography; Myocardial Perfusion; Fractional Flow Reserve

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases