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

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04316676

Collaborator

Siemens Medical Solutions (Industry)

Enrollment

Location

Arm

17.5

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Diagnostic Test: PET-MPI Protocol Diagnostic Test: CT-MPI Diagnostic Test: CT-FFR Drug: Regadenoson	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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)

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.
Coronary Flow [Day 1 (day of scans)]
Coronary flow will be measured using CT-FFR.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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)
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