NCT04316676

The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI

MyocardiAl CT Perfusion and Coronary Flow: a CompreHensive Cardiac CT Myocardial Perfusion Imaging (MPI)/Fractional Flow Reserve (FFR) and PET-CT MPI Evaluation (The MATCH Investigation)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this project is to compare the absolute quantification of myocardial perfusion done by using CT myocardial perfusion imaging (CT-MPI) and the coronary flow measured by using CT Fractional Flow Reserve analysis (CT-FFR) to the gold standard represented by PET myocardial perfusion imaging (PET-MPI).

Detailed description

Participants will be patients who are scheduled to undergo PET Myocardial Perfusion Imaging, which is the traditional method for evaluating patients with suspected blockages or narrowing of the heart vessels (coronary artery disease) causing impaired blood to flow to the heart muscle (myocardium). The purpose of the study is to determine and compare the newest heart imaging equipment which allows the non-invasive evaluation of coronary anatomy, coronary flow and myocardial perfusion in patients with suspected or proven coronary artery disease (CAD) with the actual gold-standard for quantitative myocardial perfusion assessment. In order to achieve this aim, the study team will compare heart scan results from a computed tomography (CT) Myocardial Perfusion Imaging (CT-MPI) scan and CT-Fractional Flow Reserve (FFR) with the actual standard clinical care represented by a PET Myocardial Perfusion Imaging (PET-MPI) study.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET-MPI Protocol	Patients with suspected CAD who are referred to a clinical PET-MPI will undergo the standard clinical protocol applied in the Emory Nuclear Medicine department.
DIAGNOSTIC_TEST	CT-MPI	For the CT-MPI, dynamic volume CT myocardial perfusion applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. The "dynamic shuttle" mode consists of an image acquisition during rapid, yet smooth back-and-forth movement of the CT scanner table, so that contrast media bolus passage can be evaluated within the entire left ventricle in a time-resolved fashion. This scan acquisition will be performed during pharmacologically induced stress and during rest conditions. CT-MPI studies will be contrast medium enhanced by 50-70 ml of iodinated contrast agent, administered at a flow rate of 5 mL/s. The CT examinations are scheduled within 90 days of the standard clinical PET examination.
DIAGNOSTIC_TEST	Coronary CT angiography (CCTA) for CT-FFR calculation	Coronary CT angiography (CCTA) will be performed for delineation of the coronary arteries, detection of potential coronary stenosis and FFR calculation. CCTA will be performed at rest following administration of intravenous contrast agent (50-70 mL of iodinated contrast material at a flow rate of 4-5 mL/s). A total radiation dose of approximately 8 millisievert (mSv) has expected to be administered with the stress/rest protocol to the patient. The total amount of contrast agent will not exceed 140 ml. The CT examinations are scheduled within 90 days of the standard clinical PET examination.
DRUG	Regadenoson	Pharmacological stress testing for the CT-MPI scan will be performed with a single injection of 0.4 mg of regadenoson (Lexiscan).

Timeline

• Start date: 2021-06-16
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2020-03-20
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study