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)

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: PET-MPI Protocol; Drug: Regadenoson; Diagnostic test: CT-MPI; Diagnostic test: Coronary CT angiography (CCTA) for CT-FFR calculation

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Referred for a clinically indicated CT-MPI for CAD assessment
• Must provide written informed consent prior to any study-related procedures being performed
• Must be willing to comply with all clinical study procedures

Exclusion Criteria:

• Pregnant or nursing females. The possibility of pregnancy will be excluded by testing (serum or urine ßHCG) within 24 hours before study agent administration, or if the woman has previous surgical sterilization, or if the woman is post-menopausal, with minimum one (1) year history without menses.

• Currently taking or has taken within 48 hours the following excluded medications:

  • ActoPlus Met (Pioglitazone + metformin)
  • Avandamet (Rosiglitazone + metformin)
  • Fortamet (metformin)
  • Glucovance (Glyburide +metformin)
  • Glucophage (metformin)
  • Glucophage extended-release (XR) (metformin)
  • Glumetza (metformin)
  • Janumet (Sitagliptin + metformin)
  • Metformin
  • Metaglip (Glipizide + metformin)
  • Riomet (metformin)
• Acute psychiatric disorder
• Unwilling to comply with the requirements of the protocol
• Previously entered this study
• Known hypersensitivity to iodinated contrast material, beta-blockers, or pharmaceutical stressors used in this study
• Suffers from claustrophobia
• Impaired renal function (GFR < 45 ml/min)
• Acute hypotension (<100 mm Hg systolic)
• 2nd or 3rd degree atrioventricular (AV) block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR; Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.

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.; Drug: Regadenoson; Pharmacological stress testing for the CT-MPI scan will be performed with a single injection of 0.4 mg of regadenoson (Lexiscan).; Other Names: Lexiscan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial Blood Flow	The absolute quantification of myocardial perfusion between CT-MPI and PET-MPI is compared. Myocardial perfusion is quantified using appropriate tracer kinetic models resulting myocardial blood flow mL/g/min.	Day of PET-MPI Scan, and Day of CT-MPI and CT-FFR Scans (up to 90 days)
Coronary Flow Per CT-FFR	Coronary flow is measured using the CT-FFR calculation with the CCTA scans. CT-FFR measures blood flow through coronary arteries and is used clinically to quantify the severity of CAD to determine further interventions. CT-FFR is the ratio between the blood flow (BF) in a diseased artery and a normal artery. Clinically, the CT-FFR calculation is only useful in patients with intermediate stenosis because stenosis below intermediate results in a value that is near zero and the calculation cannot be performed when stenosis is complete. The normal range for CT-FFR is greater than 0.80, values of 0.76 to 0.80 are borderline while values of 0.75 or less are associated with a high likelihood of reduced blood flow (ischemia).	Day of CT-MPI and CCTA scans
Sensitivity of Myocardial Perfusion Abnormalities Diagnosis	The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as sensitivity (true positives) with PET as the reference standard.	Day 1 (day of scans)
Specificity of Myocardial Perfusion Abnormalities Diagnosis	The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as specificity (true negatives) with PET as the reference standard.	Day 1 (day of scans)
Area Under the Curve (AUC) for Detection of Myocardial Perfusion Abnormalities	The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as overall AUC with PET as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting myocardial perfusion abnormalities with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance.	Day 1 (day of scans)
Sensitivity of Coronary Stenosis Diagnosis	The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as sensitivity (true positives) with CCTA as the reference standard.	Day 1 (day of scans)
Specificity of Coronary Stenosis Detection	The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as specificity (true negatives) with CCTA as the reference standard.	Day 1 (day of scans)
Area Under the Curve for Detection of Coronary Stenosis	The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as overall AUC with CCTA as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting coronary stenosis with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance.	Day 1 (day of scans)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Siemens Medical Solutions
• Investigators: Principal Investigator: Carlo De Cecco, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): September 24, 2024
• Study Completion (Actual): September 24, 2024

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Imaging; Atherosclerosis; Radiology; Myocardial ischemia; Nuclear medicine
• Additional Relevant MeSH Terms: Vascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine A2 Receptor Agonists; regadenoson
• Other Study ID Numbers: IRB00114434

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: Yes
• product manufactured in and exported from the U.S.: No