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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566497 on ClinicalTrials.gov