NCT05500859

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2019Dec 2035

Study Start

First participant enrolled

December 20, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

16 years

First QC Date

August 8, 2022

Last Update Submit

July 21, 2025

Conditions

Keywords

Coronary artery disease (CAD)Cardiac rehabilitation (CR)Acute coronary syndrome (ACS)Chronic coronary syndrome (CCS)Prevention benchmark performance measures (BPM)KARAMBASwiss Prevention and Rehabilitation Registry (SwissPR)

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (7)

  • Percentage of patients reaching the predefined secondary prevention benchmark after CR

    3 months after baseline

  • Change in physical activity

    up to 5 years

  • Change in medical therapy between visits

    up to 5 years

  • Change in quality of life questionnaire/ score between visits

    up to 5 years

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

    up to 5 years

  • +2 more secondary outcomes

Interventions

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Division of Outpatient Cardiology

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseAcute Coronary Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Otmar Pfister, Prof. Dr. med.

    Outpatient Cardiology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Otmar Pfister, Prof. Dr. med.

CONTACT

Steffen Biniasch

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 15, 2022

Study Start

December 20, 2019

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations