Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04712513
• Other study ID #: 12052020
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: March 2024

Study information

• Verified date: January 2021
• Source: Lawson Health Research Institute
• Contact: Aaron So, PhD
• Phone: (519)9315777
• Email: aso[@]robarts.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Canada	St Joseph's Hospital	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR), London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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