Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05500859
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2022-08-08
Brief Title:
Swiss Secondary Prevention and Rehabilitation Registry
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Swiss Secondary Prevention and Rehabilitation Registry SwissPR
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SwissPR
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None