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

No Placebo-Only Group

Summary

This trial compares surgery combined with medication to medication alone in patients with stable heart disease. It aims to find out which approach better improves blood flow and heart function.

Eligible Conditions

Coronary Artery Disease

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 105 +20 and day 365+30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in % of LV with CFCblue.

Change in % of LV with CFCgreen.

Change in CFC histogram distribution.

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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