Acute Coronary Syndromes (ACS)Cardiac RehabilitationFrailtyWomenWomen's Health
Investigational drug(s) / intervention(s)
Personalised treatmentUsual Care
Personalised treatment: Patients going through a personalized intervention program
Usual Care: Usual cardiac rehabilitation program
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Improvement in functional capacity — First visit and 3 months after hospital discharge (after completing rehabilitation program) The primary endpoint of the study will be a composite functional capacity score, designed to capture the overall improvement in cardiorespiratory fitness following the rehabilitation intervention.
This composite score will integrate the standardized change (from baseline to the end of the intervention) in the following four variables:
1. Peak oxygen uptake (VO₂ peak, in ml/kg/min), measured via cardiopulmonary exercise testing (CPET).
2. Six-minute walk distance (6MWD, in meters), assessed using the six-minute walk test.
3. Maximal metabolic equivalents (METs), achieved during CPET.
4. Exercise test duration (in minutes), defined as the total time sustained during the treadmill or cycle ergometer test under a standardized, symptom-limited protocol.
Each of these variables will be converted to z-scores based on the distribution of change scores in the study population. The composite score will be calculated as the mean of the four standardized values
Trial sites (1)
Facility
City
Region
Status
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Barcelona
Recruiting
More Institut d'Investigació Biomèdica de Bellvitge trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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