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

April 11, 2024 updated by: Carlo N. De Cecco, Emory University

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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)
  • Implanted rhythm devices (pacemaker, defibrillator)
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
Diagnostic test: CT-FFR
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Blood Flow
Time Frame: Day 1 (day of scans)
The absolute quantification of myocardial perfusion between CT-MPI and PET-MPI will be compared. Myocardial perfusion will be quantified using appropriate tracer kinetic models resulting myocardial blood flow mL/g/min.
Day 1 (day of scans)
Myocardial Blood Volume
Time Frame: Day 1 (day of scans)
The absolute quantification of myocardial perfusion between CT-MPI and PET-MPI will be compared. Myocardial perfusion will be quantified using appropriate tracer kinetic models resulting myocardial blood volume in mL/100mL.
Day 1 (day of scans)
Coronary Flow
Time Frame: Day 1 (day of scans)
Coronary flow will be measured using CT-FFR.
Day 1 (day of scans)
Detection of Myocardial Perfusion Abnormalities
Time Frame: Day 1 (day of scans)
The accuracy of detection of myocardial perfusion abnormalities will be compared between PET-MPI and the combined CT-MPI / CT-FFR approach. Diagnostic accuracy using CT-MPI and CT-FFR will be calculated in sense of sensitivity and specificity and overall AUC with PET as the reference standard.
Day 1 (day of scans)
Detection of Coronary Stenosis
Time Frame: Day 1 (day of scans)
The accuracy of detection of coronary stenosis will be compared between PET-MPI and the combined CT-MPI / CT-FFR approach. Diagnostic accuracy using CT-MPI/CT-FFR will be calculated in sense of sensitivity and specificity and overall AUC with PET as the reference standard and in correlation with the stenosis grade (%) as determined on coronary CT angiography.
Day 1 (day of scans)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Siemens Medical Solutions

Investigators

  • Principal Investigator: Carlo De Cecco, MD, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 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)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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