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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316676
• Other study ID #: IRB00114434
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Emory University
• Contact: Carlo De Cecco
• Phone: 404-712-7968
• Email: carlo.dececco[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Blood Flow	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)
Primary	Myocardial Blood Volume	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)
Primary	Coronary Flow	Coronary flow will be measured using CT-FFR.	Day 1 (day of scans)
Primary	Detection of Myocardial Perfusion Abnormalities	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)
Primary	Detection of Coronary Stenosis	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)