Evaluating follow-up strategies for asymptomatic patients after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial assesses whether clinical follow-up without systematic stress testing is as effective as regular stress testing for asymptomatic patients who have undergone coronary revascularization. It aims to determine if avoiding stress tests can prevent major cardiac events without compromising patient safety. The study will compare outcomes such as death, heart attacks, and strokes between the two follow-up strategies over a long-term period. By randomizing participants, the trial seeks to provide evidence on the best approach for monitoring these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Pitie salpetriere
  Paris, France Recruiting

Study contacts

• Principal investigator: Nadjib Hammoudi, MD PHD — Aphp(assistance Publique Des Hopitaux de Paris
• Study coordinator: Nadjib Hammoudi, MD PHD
• Email: nadjib.hammoudi@aphp.fr
• Phone: 01 42 16 55 35

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.