Early Revascularization in Stable Ischemic Heart Disease Using P.E.T. Imaging
Stopped early · Not applicable
Conditions studied: Ischemic Heart Disease
In brief
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.
Key facts
- Study ID
- NCT05018247
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 14
- Starts
- 2021-05-04
- Expected to finish
- 2022-05-19
- Last updated by the study team
- 2023-10-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Stable ischemic heart disease as determined by an investigator.
- 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.
- Willing to comply with the follow-up schedule of the trial.
- Subject must sign the informed consent in English or Spanish.
You may not qualify if…
- Any conditions that may compromise or prevent the necessary imaging requirements.
- Less than one-year life expectancy.
- Currently pregnant or planning to become pregnant during the course of the study.
- Any other issues that the Investigator believes may interfere with treatment or follow-up.
- Subjects who lack capacity to consent for themselves.
Where it is running
- Gramercy Cardiac Diagnostic Services — New York, New York, United States
Full record on ClinicalTrials.gov
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