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

Ischemic Heart Disease Clinical Trial

— PETREVASC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05018247
• Other study ID #: 20211835
• Status: Terminated
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: May 19, 2022

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention
Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

Locations

Country	Name	City	State
United States	Gramercy Cardiac Diagnostic Services	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.	CFCblue is defined as a dipyridamole induced stress flow = 0.83 ml/min/g of myocardium and a CFR = 1.27.	Baseline and Day 105+20
Primary	Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.	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.	Baseline and Day 105+20
Secondary	Change in % of LV with CFCblue.	Change in % in Left Ventricle with Coronary Flow Capacity blue.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in % of LV with CFCgreen.	Change in % of Left Ventricle with Coronary Flow Capacity green.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in CFC histogram distribution.	Change in Coronary Flow Capacity histogram distribution.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in minimum quadrant average CFR.	Change in minimum quadrant average Coronary Flow Reserve.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in minimum quadrant average stress ml/min/g.	Minimum quadrant average stress changes during PET.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in minimum stress relative quadrant average.	Change in relative minimum uptake on stress images.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in global CFR.	Change in global Coronary Flow Reserve.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in specific iso-contour defect size & its average CFR.	Change in specific iso-contour defect size & its average Coronary Flow Reserve.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in DEFECT stress ml/min/g.	Change of absolute flow in ml/min/g in the defect during stress.	Baseline and Day 105 +20 and Day 365+30
Secondary	Change in DEFECT relative stress.	Change in size and severity of stress induced perfusion defects during stress.	Baseline and Day 105 +20 and Day 365+30
Secondary	Changes in an additional 120 PET flow fields.	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	Baseline and Day 105 +20 and Day 365+30
Secondary	Rate of adverse events	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).	Baseline and Day 105 +20 and Day 365+30
Secondary	Rate of safety events.	Rate of safety events during the course of the trial such as death or adverse effects.	Baseline and Day 105 +20 and Day 365+30
Secondary	Rate of procedure-related adverse events	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.	Baseline and Day 105 +20 and Day 365+30