Assessment in a Randomized Controlled Trial 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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Prior coronary revascularization (PCI or CABG) at any time before randomization.

• Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).

• Patient affiliated to Social Security

• Informed, written consent from the patient

Locations
Other Locations
France
Pitie salpetriere
RECRUITING
Paris
Contact Information
Primary
Nadjib Hammoudi, MD PHD
nadjib.hammoudi@aphp.fr
01 42 16 55 35
Time Frame
Start Date: 2021-09-30
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 2664
Treatments
Experimental: Experimental
no systematic stress testing during follow-up
Active_comparator: Active Comparator
systematic annual stress testing during follow-up
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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