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.
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.
Assistance Publique - Hôpitaux de Paris
2,664 participants
Sep 30, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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
Exclusion Criteria14
- Age < 18years
- Any acute coronary syndrome in the previous 3 months
- Symptoms suggestive of angina pectoris at the time of randomization:
- Angina is characterized by ischemic chest pain occurring on exertion or stress relieved by rest and/or nitroglycerine.
- Angina equivalents are defined as dyspnea, fatigue, or diaphoresis on exertion evaluated by the principal investigator as abnormal and attributable to myocardial ischemia.
- Any severe valvular disease
- Prior heart transplantation
- Class III or IV symptomatic heart failure (NYHA classification).
- Persons whose occupations impact on public safety (e.g. airline pilots, lorry or bus drivers) in whom systematic stress testing could be required for medico-legal reasons
- Malignancies and other comorbid conditions with a life expectancy < 2 years
- Pregnancy or nursing women
- Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
- Simultaneous enrollment in an interventional clinical trial and interventional research with minimal risks and burden
- Inability to sign an informed consent. Patient under legal protection (guardianship, curatorship) or mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic
Systematic annual stress testing during the patient follow up (up to 48 months)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04566497