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.

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 22, 2020

Keywords

ClinConnect Summary

The ARCACHON trial is studying the best way to follow up with patients who have had heart procedures to improve blood flow, like angioplasty or bypass surgery, but who are currently not experiencing any symptoms. The researchers want to find out if regular check-ups without any stress tests are just as effective as using stress tests to monitor these patients over time. This is important because while stress tests might help identify hidden heart problems, they can also be costly and may lead to unnecessary complications.

To participate in this study, individuals must be between 65 and 74 years old, have had a heart procedure in the past, and not be showing any symptoms at the time of joining the trial. Participants will receive either regular follow-ups or a systematic stress testing approach, and they'll be closely monitored. It's important to note that certain people, such as those with recent heart issues or severe heart conditions, won't be eligible to take part in this study. Overall, this trial aims to help determine the safest and most effective follow-up care for patients after heart procedures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Prior coronary revascularization (PCI or CABG) at any time before randomization.
• • 2. Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).
• • 3. Patient affiliated to Social Security
• • 4. Informed, written consent from the patient
• Exclusion Criteria:
• • 1. Age \< 18years
• • 2. Any acute coronary syndrome in the previous 3 months
• 3. 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.
• • 4. Any severe valvular disease
• • 5. Prior heart transplantation
• • 6. Class III or IV symptomatic heart failure (NYHA classification).
• • 7. 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
• • 8. Malignancies and other comorbid conditions with a life expectancy \< 2 years
• • 9. Pregnancy or nursing women
• • 10. Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
• • 11. Simultaneous enrollment in an interventional clinical trial and interventional research with minimal risks and burden
• • 12. 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