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Cardiovascular Diseases (CVD)SwissPRNCT05500859

Swiss Secondary Prevention and Rehabilitation Registry

An observational study of Cardiovascular Diseases (CVD), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiovascular Diseases (CVD)
What is being tested?
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
How many people
4,000 participants
Where
1 siteSwitzerland
Study dates
20 Dec 2019to Dec 2035
How long will I take part?
15 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Otmar Pfister, Prof. Dr. med. contact

+41 61 328 7482

otmar.pfister@usb.ch

Steffen Biniasch contact

steffen.biniasch@usb.ch

Switzerland1 site, 1 recruiting

  • University Hospital Basel, Division of Outpatient Cardiology

    Basel, 4031

    Otmar Pfister, Prof. Dr. med., +41 61 328 7482, otmar.pfister@usb.ch

    Otmar Pfister, Prof. Dr. med.

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
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
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)
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. 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)

    Measured: 1 year

  5. 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)

    Measured: 1 year

Secondary outcomes (7)

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

    Percentage of patients reaching the predefined secondary prevention benchmark after CR

    Measured: 3 months after baseline

  2. Change in physical activity

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

    Measured: up to 5 years

  3. Change in medical therapy between visits

    Change in medical therapy between visits

    Measured: up to 5 years

  4. 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).

    Measured: up to 5 years

  5. 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)

    Measured: up to 5 years

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

    Number of total mortality after 1, 3 and 5 years

    Measured: up to 5 years

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

    Change in total MACE after 1, 3 and 5 years

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start20 Dec 2019
  3. Primary completionDec 2035 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05500859
Sponsor's protocol ID
2019-02057; me19Pfister
Other IDs
2019
Acronym
SwissPR
Status last verified
Jul 2025
First submitted
8 Aug 2022
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases (CVD), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Otmar Pfister, Prof. Dr. med. (+41 61 328 7482, otmar.pfister@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Guideline recommended medical therapy (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05500859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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