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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: PET-MPI Protocol; Diagnostic Test: CT-MPI; Diagnostic Test: CT-FFR; Drug: Regadenoson

• Registration Number: NCT04316676
• Lead Sponsor: Emory University

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Study Start: 2021-06-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR	CT-MPI	Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR	PET-MPI Protocol	Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR	CT-FFR	Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR	Regadenoson	Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.

Primary Outcome Measures

Name	Time	Method
Detection of Myocardial Perfusion Abnormalities	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.
Detection of Coronary Stenosis	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.
Myocardial Blood Volume	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.
Myocardial Blood Flow	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.
Coronary Flow	Day 1 (day of scans)	Coronary flow will be measured using CT-FFR.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States