Ischemic Heart Disease
Conditions
Keywords
Positron Emission Tomography, PET scan
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.
Interventions
PROCEDURERevascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention
Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue. | Baseline and Day 105+20 | 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. | Baseline and Day 105+20 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in CFC histogram distribution. | Baseline and Day 105 +20 and Day 365+30 | Change in Coronary Flow Capacity histogram distribution. |
| Change in minimum quadrant average CFR. | Baseline and Day 105 +20 and Day 365+30 | Change in minimum quadrant average Coronary Flow Reserve. |
| Change in minimum quadrant average stress ml/min/g. | Baseline and Day 105 +20 and Day 365+30 | Minimum quadrant average stress changes during PET. |
| Change in minimum stress relative quadrant average. | Baseline and Day 105 +20 and Day 365+30 | Change in relative minimum uptake on stress images. |
| Change in global CFR. | Baseline and Day 105 +20 and Day 365+30 | Change in global Coronary Flow Reserve. |
| Change in specific iso-contour defect size & its average CFR. | Baseline and Day 105 +20 and Day 365+30 | Change in specific iso-contour defect size & its average Coronary Flow Reserve. |
| Change in % of LV with CFCblue. | Baseline and Day 105 +20 and Day 365+30 | Change in % in Left Ventricle with Coronary Flow Capacity blue. |
| Change in DEFECT relative stress. | Baseline and Day 105 +20 and Day 365+30 | Change in size and severity of stress induced perfusion defects during stress. |
| Changes in an additional 120 PET flow fields. | Baseline and Day 105 +20 and Day 365+30 | 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 | Baseline and Day 105 +20 and Day 365+30 | 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. | Baseline and Day 105 +20 and Day 365+30 | Rate of safety events during the course of the trial such as death or adverse effects. |
| Rate of procedure-related adverse events | Baseline and Day 105 +20 and Day 365+30 | 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. |
| Change in DEFECT stress ml/min/g. | Baseline and Day 105 +20 and Day 365+30 | Change of absolute flow in ml/min/g in the defect during stress. |
| Change in % of LV with CFCgreen. | Baseline and Day 105 +20 and Day 365+30 | Change in % of Left Ventricle with Coronary Flow Capacity green. |
Countries
United States
Outcome results
None listed