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

NCT ID: NCT05018247

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2022-05-19

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

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.

Group Type: OTHER

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

Interventions

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

K.Lance Gould

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

K. Lance Gould, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health Science Center Houston

Locations

Gramercy Cardiac Diagnostic Services

New York, New York, United States

Countries

United States

Other Identifiers

20211835

Identifier Type: -

Identifier Source: org_study_id