Clinical trial NCT05500859: Swiss Secondary Prevention and Rehabilitation Registry
Official title: Swiss Secondary Prevention and Rehabilitation Registry: SwissPR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases (CVD)
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)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Guideline recommended medical therapy
timeFrame: 1 year
measure: Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value
timeFrame: 1 year
measure: Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: blood-pressure (systolic and diastolic)
timeFrame: 1 year
measure: Change in smoking status
timeFrame: 1 year
measure: Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: exercise/ week
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of patients reaching the predefined secondary prevention benchmark after CR
timeFrame: 3 months after baseline
measure: Change in physical activity
timeFrame: up to 5 years
measure: Change in medical therapy between visits
timeFrame: up to 5 years
measure: Change in quality of life questionnaire/ score between visits
timeFrame: up to 5 years
measure: Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P) between visits
timeFrame: up to 5 years
measure: Change in total mortality after 1, 3 and 5 years
timeFrame: up to 5 years
measure: Change in total MACE after 1, 3 and 5 years
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Outpatient Cardiology
Study officials:
affiliation: Outpatient Cardiology, University Hospital Basel
name: Otmar Pfister, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: