Patient-centered Personalized Cardiac Rehabilitation in Post Acute Coronary Syndrome (BREAK-trial)
Launched by INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE · Jun 17, 2025
Trial Information
Current as of July 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new type of heart rehabilitation program designed especially for people recovering from a recent heart event called Acute Coronary Syndrome (ACS), which includes heart attacks and similar conditions. The goal is to see if a personalized, patient-focused program—one that pays special attention to women and those who may be more fragile or have extra needs—works better than the usual heart rehabilitation care. Heart rehabilitation programs help patients recover and improve their heart health through exercise, education, and support.
People who might be eligible to join are adults aged 18 or older who have recently been hospitalized for a heart event like ACS and are ready to start recovery within about a month after leaving the hospital. Participants need to be able to communicate with the study team and agree to take part by signing a consent form. During the study, participants will either follow this new personalized rehabilitation program or the standard care, and researchers will compare the results. The study is currently looking for volunteers and aims to better support patients’ needs, especially focusing on women’s health and those who may be more vulnerable during recovery.
Gender
ALL
Eligibility 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
About Institut D'investigació Biomèdica De Bellvitge
The Institut d'Investigació Biomèdica de Bellvitge (IDIBELL) is a leading biomedical research institute located in Bellvitge, Spain, dedicated to advancing medical knowledge and improving patient care through innovative research. Affiliated with the Bellvitge University Hospital and the University of Barcelona, IDIBELL focuses on a wide range of biomedical fields, including cancer, neuroscience, and regenerative medicine. The institute fosters collaboration among researchers, clinicians, and industry partners to facilitate the translation of scientific discoveries into clinical applications, ultimately aiming to enhance health outcomes and contribute to the development of groundbreaking therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
L'hospitalet De Llobregat, Barcelona, Spain
Patients applied
Trial Officials
Cristina Enjuanes, MD, PhD
Principal Investigator
Institut d'Investigació Biomèdica de Bellvitge
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported