Early Revascularization in Stable Ischemic Heart Disease Using P.E.T. Imaging (PETREVASC)

A Prospective, Randomized Trial of Early Revascularization in Stable Ischemic Heart Disease Guided by Positron Emission Tomography of Artery Specific Integrated Comprehensive Quantitative Myocardial Perfusion

To compare the impact of revascularization and Optimal Medical Treatment (OMT) on the extent of severely reduced coronary flow capacity in stable ischemic heart disease.

Study Overview

• Status: Terminated
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

Detailed Description

The initial Positron Emission Tomography (PET) scan will be performed as part of clinical practice. If the patient is a potential candidate for the study, the patient will be screened for inclusion and exclusion criteria. After being informed about the study potential risks, all patients giving written informed consent will be randomized into one of two groups: Urgent revascularization combined with Optimal Medical Treatment (OMT) or OMT with delayed revascularization. Following the initial PET scan, randomization and treatment, each group will undergo a second PET scan at the 3-4 month mark and a third PET scan at the one year mark. Some crossover may occur with the two groups. The OMT without urgent revascularization patients will remain in that group, if clinically stable, up to three months. At their first follow-up visit (Day 105±20), patients will be offered the option of continued medical treatment or elective revascularization consistent with informed patient preference and clinical judgement. Patients, in consultation with their physicians, may elect to undergo revascularization at any time thereafter.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Gramercy Cardiac Diagnostic Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Stable ischemic heart disease as determined by an investigator.

3. Areas of severely reduced CFC or relative stress images on the Rentrop diagnostic PET MPI consistent with clinical judgement as follows:

   • PETs with a defect on rest relative images of ≤60% of max for ≤5% of LV (no large scar) plus: i. ≥2% of LV with CFCblue* or ii. ≥10% of LV with CFCgreen* plus at least one pixel with CFCblue*

   *CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.27. CFCgreen is defined as a dipyridamole induced stress flow ≤1.09 and >0.83 ml/min/g of myocardium and a CFR ≤1.60 and >1.27.

4. Willing to comply with the follow-up schedule of the trial.
5. Subject must sign the informed consent in English or Spanish.

Exclusion Criteria:

1. Any conditions that may compromise or prevent the necessary imaging requirements.
2. Less than one-year life expectancy.
3. Currently pregnant or planning to become pregnant during the course of the study.
4. Any other issues that the Investigator believes may interfere with treatment or follow-up.
5. Subjects who lack capacity to consent for themselves.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Urgent revascularization with Optimal Medical Therapy; Revascularization will be performed via either Percutaneous Coronary Intervention or Coronary Artery Bypass Graft, and the selection of the specific procedure will be at the discretion of the patient and their physician(s). Patients will be followed for one year after randomization. Follow-up visits will occur at Baseline, Day 105, and Day 365. At each visit, a rest-stress PET assessment will be performed, and adverse events related to study procedures and cardiac disease will be captured.	Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention; Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment
Other: Optimal Medical Treatment with delayed revascularization; OMT without revascularization for a minimum of approximately 105 days if clinically stable. At their first follow-up visit (Day 105±20), patients will be offered the option of continued medical treatment or elective revascularization consistent with informed patient preference and clinical judgement. Patients, in consultation with their physicians, may elect to undergo revascularization at any time thereafter and will be followed for one year after randomization. Follow-up visits will occur at Baseline, Day 105, and Day 365. At each visit, a rest-stress PET assessment will be performed, and adverse events related to study procedures and cardiac disease will be captured.	Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention; Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.	CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.27.	Baseline and Day 105+20
Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.	CFCgreen is defined as a dipyridamole induced stress flow ≤1.09 and >0.83 ml/min/g of myocardium and a CFR ≤1.60 and >1.27.	Baseline and Day 105+20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in % of LV with CFCblue.	Change in % in Left Ventricle with Coronary Flow Capacity blue.	Baseline and Day 105 +20 and Day 365+30
Change in % of LV with CFCgreen.	Change in % of Left Ventricle with Coronary Flow Capacity green.	Baseline and Day 105 +20 and Day 365+30
Change in CFC histogram distribution.	Change in Coronary Flow Capacity histogram distribution.	Baseline and Day 105 +20 and Day 365+30
Change in minimum quadrant average CFR.	Change in minimum quadrant average Coronary Flow Reserve.	Baseline and Day 105 +20 and Day 365+30
Change in minimum quadrant average stress ml/min/g.	Minimum quadrant average stress changes during PET.	Baseline and Day 105 +20 and Day 365+30
Change in minimum stress relative quadrant average.	Change in relative minimum uptake on stress images.	Baseline and Day 105 +20 and Day 365+30
Change in global CFR.	Change in global Coronary Flow Reserve.	Baseline and Day 105 +20 and Day 365+30
Change in specific iso-contour defect size & its average CFR.	Change in specific iso-contour defect size & its average Coronary Flow Reserve.	Baseline and Day 105 +20 and Day 365+30
Change in DEFECT stress ml/min/g.	Change of absolute flow in ml/min/g in the defect during stress.	Baseline and Day 105 +20 and Day 365+30
Change in DEFECT relative stress.	Change in size and severity of stress induced perfusion defects during stress.	Baseline and Day 105 +20 and Day 365+30
Changes in an additional 120 PET flow fields.	Changes in 120 PET flow fields derived in the CORE lab comparing Rentrop PETs with reprocessed PETs at University of Texas Health Science Center Houston	Baseline and Day 105 +20 and Day 365+30
Rate of adverse events	Rate of major adverse cardiovascular events (defined as death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest).	Baseline and Day 105 +20 and Day 365+30
Rate of safety events.	Rate of safety events during the course of the trial such as death or adverse effects.	Baseline and Day 105 +20 and Day 365+30
Rate of procedure-related adverse events	Rate of procedure-related adverse events such as death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.	Baseline and Day 105 +20 and Day 365+30

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: K. Lance Gould, MD, UT Health Science Center Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): May 19, 2022
• Study Completion (Actual): May 19, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PET scan; Positron Emission Tomography
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 20211835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No