Clinical trial NCT04316676: The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Atherosclerosis
Cardiovascular disease
Myocardial ischemia
Imaging
Nuclear medicine
Radiology
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2020-03-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial Blood Flow
timeFrame: Day 1 (day of scans)
measure: Myocardial Blood Volume
timeFrame: Day 1 (day of scans)
measure: Coronary Flow
timeFrame: Day 1 (day of scans)
measure: Detection of Myocardial Perfusion Abnormalities
timeFrame: Day 1 (day of scans)
measure: Detection of Coronary Stenosis
timeFrame: Day 1 (day of scans)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Carlo De Cecco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: