Personalized cardiac rehabilitation after an acute coronary event, focused on women and frail patients

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.