Clinical trial NCT05018247: Early Revascularization in Stable Ischemic Heart Disease Using P.E.T. Imaging
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
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Positron Emission Tomography
PET scan
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.
timeFrame: Baseline and Day 105+20
measure: Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.
timeFrame: Baseline and Day 105+20
Secondary outcomes:
measure: Change in % of LV with CFCblue.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in % of LV with CFCgreen.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in CFC histogram distribution.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in minimum quadrant average CFR.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in minimum quadrant average stress ml/min/g.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in minimum stress relative quadrant average.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in global CFR.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in specific iso-contour defect size & its average CFR.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in DEFECT stress ml/min/g.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Change in DEFECT relative stress.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Changes in an additional 120 PET flow fields.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Rate of adverse events
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Rate of safety events.
timeFrame: Baseline and Day 105 +20 and Day 365+30
measure: Rate of procedure-related adverse events
timeFrame: Baseline and Day 105 +20 and Day 365+30
Other outcomes:
Locations:
city: New York
country: United States
facility: Gramercy Cardiac Diagnostic Services
state: New York
Study officials:
affiliation: UT Health Science Center Houston
name: K. Lance Gould, MD
role: PRINCIPAL_INVESTIGATOR
References: