Evaluating follow-up strategies for asymptomatic patients after heart surgery
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.
This study is testing if regular check-ups without stress tests are just as safe and effective for heart surgery patients who don’t have symptoms, compared to those who do have stress tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2664 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04566497 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic patients with a history of coronary revascularization who are stable on their current medical treatment.
Not a fit: Patients with recent acute coronary syndrome or those exhibiting symptoms suggestive of angina will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more cost-effective and safer follow-up care for patients after coronary revascularization.
How similar studies have performed: While there is limited evidence from randomized trials on this specific approach, the study aims to fill a gap in knowledge regarding follow-up strategies for asymptomatic patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.