Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

Multicenter Diagnostic Performance of Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Dynamic cardiac CT perfusion imaging

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Aaron So, PhD; Phone Number: 24224 (519)9315777; Email: aso@robarts.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St Joseph's Hospital
      • Contact: Aaron So, PhD; Phone Number: 24224 (519)9315777; Email: aso@robarts.ca
      • Principal Investigator: Aaron So, PhD
      • Sub-Investigator: Patrick Teefy, MD
      • Sub-Investigator: Shahar Lavi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Computed Tomography; Fractional Flow Reserve; Myocardial Perfusion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 12052020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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