NCT07038265 Patient-centered Personalized Cardiac Rehabilitation in Post Acute Coronary Syndrome (BREAK-trial)
| NCT ID | NCT07038265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge |
| Condition | Acute Coronary Syndromes (ACS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 202 participants in total. It began in 2025-05-26 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to compare an integrated, multidisciplinar patient-centered CRP (Cardiac Rehabilitation Program) (intervention group) especially focused on covering the needs for the female and fragile population to the usual care conventional CRP (control group)
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
Contact & Investigator
Cristina Enjuanes, MD, PhD
PRINCIPAL INVESTIGATOR
Institut d'Investigació Biomèdica de Bellvitge
Frequently Asked Questions
Who can join the NCT07038265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndromes (ACS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07038265 currently recruiting?
Yes, NCT07038265 is actively recruiting participants. Contact the research team at cenjuanes@bellvitgehospital.cat for enrollment information.
Where is the NCT07038265 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain.
Who is sponsoring the NCT07038265 clinical trial?
NCT07038265 is sponsored by Institut d'Investigació Biomèdica de Bellvitge. The principal investigator is Cristina Enjuanes, MD, PhD at Institut d'Investigació Biomèdica de Bellvitge. The trial plans to enroll 202 participants.