Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
NCT04566497 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2664
Last updated 2024-06-03
Summary
Due to the lack of randomized controlled trials, the best follow-up strategy of asymptomatic patients after coronary artery revascularization is controversial. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results can cause unexpected complications.
ARCACHON is a national, multicenter, randomized, open label trial, that will evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization.
Conditions
- Coronary Artery Disease
- Percutaneous Coronary Intervention
- Coronary Artery Bypass Grafting
Interventions
- OTHER
-
No stress testing
No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic
- PROCEDURE
-
stress testing
Systematic annual stress testing during the patient follow up (up to 48 months)
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Nadjib Hammoudi, MD PHD · APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-30
- Primary Completion
- 2025-09-30
- Completion
- 2025-09-30
Countries
- France
Study Locations
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