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

Emory University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Drug: Regadenoson; Diagnostic Test: CT-MPI; Diagnostic Test: CT-FFR; Diagnostic Test: PET-MPI Protocol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04316676

IRB00114434

Details and patient eligibility

About

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).

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

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

Other group

Description:

Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.

Treatment:

Diagnostic Test: CT-FFR

Diagnostic Test: PET-MPI Protocol

Diagnostic Test: CT-MPI

Drug: Regadenoson