Swiss Secondary Prevention and Rehabilitation Registry (SwissPR)

Swiss Secondary Prevention and Rehabilitation Registry: SwissPR

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases (CVD)
• Intervention / Treatment: Other: 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

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Otmar Pfister, Prof. Dr. med.; Phone Number: +41 61 328 7482; Email: otmar.pfister@usb.ch
• Study Contact Backup: Name: Steffen Biniasch; Email: steffen.biniasch@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel, Division of Outpatient Cardiology
    • Contact: Otmar Pfister, Prof. Dr. med.; Phone Number: +41 61 328 7482; Email: otmar.pfister@usb.ch
    • Principal Investigator: Otmar Pfister, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Guideline recommended medical therapy	Change in Guideline recommended medical therapy (Guideline recommended medical therapy is one variable in predefined secondary prevention benchmark performance measures (BPM) at one year after CR)	1 year
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value	Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value	1 year
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: blood-pressure (systolic and diastolic)	Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of target blood-pressure	1 year
Change in smoking status	Change in smoking status (smoking status is a predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of Non-smoking status)	1 year
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: exercise/ week	Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of 150 minutes of exercise/ week (self-reported)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients reaching the predefined secondary prevention benchmark after CR	Percentage of patients reaching the predefined secondary prevention benchmark after CR	3 months after baseline
Change in physical activity	Change in physical activity (measured by exercise capacity (Watt) since last follow-up	up to 5 years
Change in medical therapy between visits	Change in medical therapy between visits	up to 5 years
Change in quality of life questionnaire/ score between visits	Change in quality of life questionnaire between visits. The questionnaire covers various attributes of an individuals life, summing the items for each life area for a total score (possible score range 0-96).	up to 5 years
Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P) between visits	Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P): 3 categories: G1 (Low-risk; TRS-2P = 0/1); G2 (Intermediate-risk; TRS-2P = 2); and, G3 (High-risk; TRS-2P ≥ 3)	up to 5 years
Change in total mortality after 1, 3 and 5 years	Number of total mortality after 1, 3 and 5 years	up to 5 years
Change in total MACE after 1, 3 and 5 years	Change in total MACE after 1, 3 and 5 years	up to 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Otmar Pfister, Prof. Dr. med., Outpatient Cardiology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Coronary artery disease (CAD); Cardiac rehabilitation (CR); Acute coronary syndrome (ACS); Chronic coronary syndrome (CCS); Prevention benchmark performance measures (BPM); KARAMBA; Swiss Prevention and Rehabilitation Registry (SwissPR)
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2019-02057; me19Pfister

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No