Terminated prematurely due to closure of the PET imaging facility

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.

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 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.