Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease

NCT04712513 | Unknown

• 1 other identifier: 12052020
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

Computed Tomography; Myocardial Perfusion; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques

  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

  Within 4 weeks prior to invasive cardiac catheterization

Study Arms (1)

Patients with coronary artery disease and hemodynamically stable

Diagnostic Test: Dynamic cardiac CT perfusion imaging

Interventions

Dynamic cardiac CT perfusion imaging 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.

Patients with coronary artery disease and hemodynamically stable

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• London Health Sciences Centre: collaborator

Study Sites (1)

St Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aaron So, PhD

CONTACT

(519)9315777; aso@robarts.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)