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

NCT04316676 | Completed Results FDA Device

• 1 other identifier: IRB00114434
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Coronary Artery Disease

Keywords

Atherosclerosis; Cardiovascular disease; Myocardial ischemia; Imaging; Nuclear medicine; Radiology

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (1)

Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR

OTHER

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; Diagnostic Test: CT-MPI; Diagnostic Test: Coronary CT angiography (CCTA) for CT-FFR calculation; Drug: Regadenoson

Interventions

CT-MPI DIAGNOSTIC_TEST

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.

Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR

Coronary CT angiography (CCTA) for CT-FFR calculation DIAGNOSTIC_TEST

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.

Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR

Regadenoson DRUG

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

Also known as: Lexiscan

Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR

PET-MPI Protocol DIAGNOSTIC_TEST

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.

Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Cardiovascular Diseases; Myocardial Ischemia

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Carlo De Cecco, MD, PhD
• Organization: Emory University

carlo.dececco@emory.edu

404-712-7968

Study Officials

• Carlo De Cecco, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 20, 2020
• Study Start: June 16, 2021
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)