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Search / Trial NCT07038265

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

Frailty Sarcopenia Cardiac Rehabilitation Gender Perspective Acute Coronary Syndrome Coronary Artery Disease Patient Centered Care

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.

Locations

L'hospitalet De Llobregat, Barcelona, Spain

Patients applied

0 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