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

The University of Texas Health Science Center, Houston14 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Heart Disease

Interventions

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary InterventionPROCEDURE

Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Gramercy Cardiac Diagnostic Services

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline and Day 105+20