Swiss Secondary Prevention and Rehabilitation Registry

NCT ID: NCT05500859

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2035-12-31

Brief Summary

The SwissPR study is to continuously monitor patient characteristics and short- and long-term benchmark quality measures and outcomes of patients participating in a 12-week ambulatory CR program.

Detailed Description

The SwissPR study is a non-interventional, longitudinal observational cohort study consisting of a retrospective and a prospective part of patients who have completed the Cardiac Rehabilitation (CR) program of the University Hospital Basel. Assessing the impact of a CR program on key cardiovascular Benchmark Performance Measures (BPM) and its persistence over time would be helpful on internal quality control as well as identification of special need patients with highest cardiovascular risk. "KARAMBA" is the outpatient cardiovascular prevention and rehabilitation program of the University Hospital Basel (USB) and is one of the largest CR centers in Switzerland. Data regarding the Swiss population during and after CR is missing so far, thus creating a Swiss Prevention and Rehabilitation Registry (= SwissPR) on the basis of the KARAMBA infrastructure has the potential to collect missing data and address these questions. The results of the study will identify patient profiles at increased risk (special need patients) and will shed light into the mechanisms of poor secondary prevention behavior. The objective of SwissPR is to continuously monitor patient characteristics and short- and long-term benchmark quality measures and outcomes of patients participating in a 12-week ambulatory CR program.

For the prospective and retrospective part no recruitment or screening procedure is required. The procedure of enrolling patients for the prospective cohort of SwissPR patients is based on the participation in the CR program of the University Hospital Basel. Patients are routinely referred by various institutions for participation in the CR program according to predefined cardiovascular diagnosis. The retrospective part applies to data of patients, which have completed the CR program in Basel between 2017 and 2019.

Procedures:

Visit 1: Baseline, start of ambulatory CR program (approx. 60min): Patient characteristics including medical history, current medication, cardiovascular risk factors, routine laboratory analysis (including lipids, Hb1c, NT-proBNP), clinical status, electrocardiogram, echocardiography data from latest echo, cardio pulmonary exercise testing (CPET), questions on general health behavior (diet, weekly exercise load), Quality of Life and questions on socio-economic parameters.

Visit 2: End of CR program, 3 months after baseline (approx. 60 min.): Same measurements and procedures as at visit 1.

Visit 3: 1-year follow-up (approx. 15 min.): Same measurements and procedures as at visit 1 and 2 except for CPET.

Telephone follow-up and questionnaire 3 years after CR (approx. 15 min.): After checking vital status, the following end-points and information will be collected by telephone interview: hospitalisations since last follow-up (cardiac, non-cardiac), Major Cardiovascular Adverse Events (MACE) including cardiovascular mortality, myocardial infarction, stroke, revascularization, hospitalization for heart failure, smoking status and physical activity. The questionnaire contains questions on health behaviour, quality of life, depression and medication.

Telephone follow-up and questionnaire 5 years after CR (approx. 15 min.): Same interview and questionnaire as at 3-year follow-up.

Conditions

Cardiovascular Diseases (CVD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Data collection at Baseline, 3 months after baseline (BL), 1-year follow-up, Telephone follow-up and questionnaire 3 years and 5 years after BL

Data collection (Patient characteristics including medical history, current medication, cardiovascular risk factors, routine laboratory analysis (including lipids, Hb1c, NT-proBNP), clinical status, electrocardiogram, echocardiography data from latest echo, cardio pulmonary exercise testing (CPET), questions on general health behavior (diet, weekly exercise load), Quality of Life and questions on socio-economic parameters)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participation in an ambulatory CR program (all age groups)
• Written informed consent

Exclusion Criteria

• Inability to follow an ambulatory CR program more than 3 weeks
• Not willing to give informed consent
• Inability to understand the informed consent due to language comprehension
• Lack of discernment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Otmar Pfister, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Outpatient Cardiology, University Hospital Basel

Locations

University Hospital Basel, Division of Outpatient Cardiology

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Otmar Pfister, Prof. Dr. med.

Role: CONTACT

otmar.pfister@usb.ch

+41 61 328 7482

Steffen Biniasch

Role: CONTACT

steffen.biniasch@usb.ch

Facility Contacts

Otmar Pfister, Prof. Dr. med.

Role: primary

otmar.pfister@usb.ch

+41 61 328 7482

Other Identifiers

2019-02057; me19Pfister

Identifier Type: -

Identifier Source: org_study_id