Back to results

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

Primary Purpose

Ischemic Heart Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Positron Emission Tomography, PET scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Stable ischemic heart disease as determined by an investigator.
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.
Willing to comply with the follow-up schedule of the trial.
Subject must sign the informed consent in English or Spanish.

Exclusion Criteria:

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

Sites / Locations

Gramercy Cardiac Diagnostic Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Urgent revascularization with Optimal Medical Therapy

Optimal Medical Treatment with delayed revascularization

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change in % of LV with CFCblue.

Change in % in Left Ventricle with Coronary Flow Capacity blue.

Change in % of LV with CFCgreen.

Change in % of Left Ventricle with Coronary Flow Capacity green.

Change in CFC histogram distribution.

Change in Coronary Flow Capacity histogram distribution.

Change in minimum quadrant average CFR.

Change in minimum quadrant average Coronary Flow Reserve.

Change in minimum quadrant average stress ml/min/g.

Minimum quadrant average stress changes during PET.

Change in minimum stress relative quadrant average.

Change in relative minimum uptake on stress images.

Change in global CFR.

Change in global Coronary Flow Reserve.

Change in specific iso-contour defect size & its average CFR.

Change in specific iso-contour defect size & its average Coronary Flow Reserve.

Change in DEFECT stress ml/min/g.

Change of absolute flow in ml/min/g in the defect during stress.

Change in DEFECT relative stress.

Change in size and severity of stress induced perfusion defects during stress.

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

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).

Rate of safety events.

Rate of safety events during the course of the trial such as death or adverse effects.

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.

Full Information

NCT ID

NCT05018247

First Posted

August 10, 2021

Last Updated

October 16, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05018247

Brief Title

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

Acronym

PETREVASC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

Terminated prematurely due to closure of the PET imaging facility

Study Start Date

May 4, 2021 (Actual)

Primary Completion Date

May 19, 2022 (Actual)

Study Completion Date

May 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

Positron Emission Tomography, PET scan

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

After randomization, patients will receive urgent revascularization combined with Optimal Medical Treatment or Optimal Medical Treatment 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. At their first follow-up visit (3-4 month mark), patients in the OMT with delayed revascularization group 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.

Masking

None (Open Label)

Masking Description

Study personnel and subjects will not be blinded. All core lab measurements, comparisons, and statistical analysis will be blinded to group assignment by blinded coding of PET images. Two volunteers who are not involved in the study in any way to create randomization envelopes with each arm. The study staff volunteers for randomization assignment will: Create a randomization list with two arms (52 per arm). Create 104 sequential envelopes which will contain a paper with the assignment based on the randomization list. The sequential randomization envelopes will be kept in the site PI's locked office thereby allowing for randomization immediately after consent is obtained. The randomization arm will be shared with the research team and the subject.

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Urgent revascularization with Optimal Medical Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Optimal Medical Treatment with delayed revascularization

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

Intervention Description

Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

Primary Outcome Measure Information:

Title

Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.

Description

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

Time Frame

Baseline and Day 105+20

Title

Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.

Description

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.

Time Frame

Baseline and Day 105+20

Secondary Outcome Measure Information:

Title

Change in % of LV with CFCblue.

Description

Change in % in Left Ventricle with Coronary Flow Capacity blue.

Time Frame