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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET-MPI Protocol
CT-MPI
CT-FFR
Regadenoson
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Atherosclerosis, Cardiovascular disease, Myocardial ischemia, Imaging, Nuclear medicine, Radiology

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Emory University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
Coronary Flow
Coronary flow will be measured using CT-FFR.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2020
Last Updated
March 31, 2023
Sponsor
Emory University
Collaborators
Siemens Medical Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT04316676
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Siemens Medical Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Atherosclerosis, Cardiovascular disease, Myocardial ischemia, Imaging, Nuclear medicine, Radiology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR
Arm Type
Other
Arm Description
Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET-MPI Protocol
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT-MPI
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT-FFR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Regadenoson
Other Intervention Name(s)
Lexiscan
Intervention Description
Pharmacological stress testing for the CT-MPI scan will be performed with a single injection of 0.4 mg of regadenoson (Lexiscan).
Primary Outcome Measure Information:
Title
Myocardial Blood Flow
Description
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.
Time Frame
Day 1 (day of scans)
Title
Myocardial Blood Volume
Description
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.
Time Frame
Day 1 (day of scans)
Title
Coronary Flow
Description
Coronary flow will be measured using CT-FFR.
Time Frame
Day 1 (day of scans)
Title
Detection of Myocardial Perfusion Abnormalities
Description
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.
Time Frame
Day 1 (day of scans)
Title
Detection of Coronary Stenosis
Description
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.
Time Frame
Day 1 (day of scans)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo De Cecco
Phone
404-712-7968
Email
carlo.dececco@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo De Cecco, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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