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NCT Number: NCT05500859

Swiss Secondary Prevention and Rehabilitation Registry

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Division of Outpatient Cardiology

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Otmar Pfister, Prof. Dr. med.

CONTACT

[email protected]

+41 61 328 7482

Otmar Pfister, Prof. Dr. med.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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)

Primary outcomes

  1. Change in Guideline recommended medical therapy

    Time frame: 1 year

    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)

  2. Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value

    Time frame: 1 year

    Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value

  3. Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: blood-pressure (systolic and diastolic)

    Time frame: 1 year

    Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of target blood-pressure

  4. Change in smoking status

    Time frame: 1 year

    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)

  5. Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: exercise/ week

    Time frame: 1 year

    Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of 150 minutes of exercise/ week (self-reported)

Secondary outcomes

  1. Percentage of patients reaching the predefined secondary prevention benchmark after CR

    Time frame: 3 months after baseline

    Percentage of patients reaching the predefined secondary prevention benchmark after CR

  2. Change in physical activity

    Time frame: up to 5 years

    Change in physical activity (measured by exercise capacity (Watt) since last follow-up

  3. Change in medical therapy between visits

    Time frame: up to 5 years

    Change in medical therapy between visits

  4. Change in quality of life questionnaire/ score between visits

    Time frame: up to 5 years

    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).

  5. Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P) between visits

    Time frame: up to 5 years

    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)

  6. Change in total mortality after 1, 3 and 5 years

    Time frame: up to 5 years

    Number of total mortality after 1, 3 and 5 years

  7. Change in total MACE after 1, 3 and 5 years

    Time frame: up to 5 years

    Change in total MACE after 1, 3 and 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Otmar Pfister, Prof. Dr. med.

CONTACT

[email protected]

+41 61 328 7482

Steffen Biniasch

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Swiss Secondary Prevention and Rehabilitation Registry: SwissPR

Acronym: SwissPR

Important dates

Study start
2019
Primary completion
2035
Study completion
2035
First posted
Aug 15, 2022
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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