Personalized cardiac rehabilitation after an acute coronary event, focused on women and frail patients
Patient-centered Cardiac rehaBilitation pRogramE in Post Acute Coronary Syndrome:Identification of Key Barriers and Evaluation of Personalized Intervention (BREAK-trial)
This project will test a personalized, patient-centered cardiac rehabilitation program to see if it helps people—especially women and frail patients—recover better after an acute coronary syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge Academic / other |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT07038265 on ClinicalTrials.gov |
What this trial studies
The BREAK-CR program is a single-center, open-label randomized controlled trial with blinded end-point adjudication that compares an integrated, multidisciplinary, patient-centered cardiac rehabilitation program to usual care for patients recently hospitalized with an acute coronary syndrome. The study begins with a qualitative phase to identify barriers and facilitators to program participation among women and frail patients and then implements a tailored intervention based on those findings. Key outcomes include feasibility, adherence, functional capacity, safety, patient satisfaction, and quality of life. Participants are randomized to the personalized program or standard cardiac rehabilitation and followed through program completion to compare incorporation and clinical outcomes.
Who should consider this trial
Good fit: Adults (≥18) discharged within 30 days after an acute coronary syndrome who can communicate and provide informed consent, particularly women and those identified as frail or with sarcopenia, are ideal candidates.
Not a fit: Patients who are institutionalized, have life expectancy under one year, have severe cognitive or psychiatric impairment without caregiver support, have planned major cardiac surgery or transplant, or cannot consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could increase enrollment and adherence to cardiac rehabilitation among women and frail survivors, improving functional recovery, satisfaction, and quality of life.
How similar studies have performed: Prior smaller and targeted rehabilitation programs have shown that tailored, gender-sensitive approaches can boost participation and outcomes, but comprehensive interventions explicitly designed for women and frail ACS survivors remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient aged ≥ 18 years 2. Patients discharged within the last 30 days after an admission for ACS or in the discharge planning process for an admission for ACS. 3. The patient is able to fully communicate with the research team and comply with all study procedures. 4. The patient voluntarily signs and dates the informed consent form approved by the ethics committee Exclusion Criteria: 1. Age \<18 years 2. Participation in another clinical trial 3. Moderate or severe cognitive impairment in the absence of a competent caregiver 4. Absence of social support 5. Institutionalized patient 6. Life expectancy \<1 year 7. Candidates for end-of-life care 8. Severe psychiatric illness 9. Planned cardiac surgery including transplant or circulatory support implant 10. Death before hospital discharge in patients included in the hospital discharge planning phase 11. Carrier of heart transplant. 12. Patient unable or refusing to give written informed consent to participate 13. Patients who, in the opinion of the investigator, are unsuitable candidates for the study
Where this trial is running
L'Hospitalet de Llobregat, Barcelona
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Cristina Enjuanes, MD, PhD — Institut d'Investigació Biomèdica de Bellvitge
- Study coordinator: Cristina Enjuanes Grau, MD, PhD
- Email: cenjuanes@bellvitgehospital.cat
- Phone: +34 93 260 7078
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.