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Procedure
Optimal Medical Treatment with delayed revascularization for Coronary Artery Disease (PETREVASC Trial)
N/A
Waitlist Available
Led By K. Lance Gould, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 105 +20 and day 365+30
Awards & highlights
PETREVASC Trial Summary
This trial is comparing the two most common treatments for stable ischemic heart disease: revascularization (surgery to improve blood flow to the heart) and Optimal Medical Treatment (a combination of drugs to improve symptoms and reduce risk). The goal is to see which treatment is better at improving severely reduced coronary flow capacity.
Eligible Conditions
- Coronary Artery Disease
PETREVASC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 105 +20 and day 365+30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 105 +20 and day 365+30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.
Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.
Secondary outcome measures
Change in % of LV with CFCblue.
Change in % of LV with CFCgreen.
Change in CFC histogram distribution.
+11 morePETREVASC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Optimal Medical Treatment with delayed revascularizationExperimental Treatment1 Intervention
OMT without revascularization for a minimum of approximately 105 days if clinically stable. 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 and will be followed for one year after randomization. Follow-up visits will occur at Baseline, Day 105, and Day 365. At each visit, a rest-stress PET assessment will be performed, and adverse events related to study procedures and cardiac disease will be captured.
Group II: Urgent revascularization with Optimal Medical TherapyActive Control1 Intervention
Revascularization will be performed via either Percutaneous Coronary Intervention or Coronary Artery Bypass Graft, and the selection of the specific procedure will be at the discretion of the patient and their physician(s). Patients will be followed for one year after randomization. Follow-up visits will occur at Baseline, Day 105, and Day 365. At each visit, a rest-stress PET assessment will be performed, and adverse events related to study procedures and cardiac disease will be captured.
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,946 Total Patients Enrolled
7 Trials studying Coronary Artery Disease
7,895 Patients Enrolled for Coronary Artery Disease
K. Lance Gould, MDPrincipal InvestigatorUT Health Science Center Houston
1 Previous Clinical Trials
1,085 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
1,085 Patients Enrolled for Coronary Artery Disease
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