Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-04-17 @ 8:28 PM
Study NCT ID:
NCT05500859
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swiss Secondary Prevention and Rehabilitation Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Guideline recommended medical therapy', 'timeFrame': '1 year', 'description': '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)'}, {'measure': 'Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value', 'timeFrame': '1 year', 'description': 'Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value'}, {'measure': 'Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: blood-pressure (systolic and diastolic)', 'timeFrame': '1 year', 'description': 'Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of target blood-pressure'}, {'measure': 'Change in smoking status', 'timeFrame': '1 year', 'description': '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)'}, {'measure': 'Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: exercise/ week', 'timeFrame': '1 year', 'description': 'Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of 150 minutes of exercise/ week (self-reported)'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients reaching the predefined secondary prevention benchmark after CR', 'timeFrame': '3 months after baseline', 'description': 'Percentage of patients reaching the predefined secondary prevention benchmark after CR'}, {'measure': 'Change in physical activity', 'timeFrame': 'up to 5 years', 'description': 'Change in physical activity (measured by exercise capacity (Watt) since last follow-up'}, {'measure': 'Change in medical therapy between visits', 'timeFrame': 'up to 5 years', 'description': 'Change in medical therapy between visits'}, {'measure': 'Change in quality of life questionnaire/ score between visits', 'timeFrame': 'up to 5 years', 'description': '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).'}, {'measure': 'Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P) between visits', 'timeFrame': 'up to 5 years', 'description': '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)'}, {'measure': 'Change in total mortality after 1, 3 and 5 years', 'timeFrame': 'up to 5 years', 'description': 'Number of total mortality after 1, 3 and 5 years'}, {'measure': 'Change in total MACE after 1, 3 and 5 years', 'timeFrame': 'up to 5 years', 'description': 'Change in total MACE after 1, 3 and 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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)'], 'conditions': ['Cardiovascular Diseases (CVD)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nFor 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.\n\nProcedures:\n\nVisit 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.\n\nVisit 2: End of CR program, 3 months after baseline (approx. 60 min.): Same measurements and procedures as at visit 1.\n\nVisit 3: 1-year follow-up (approx. 15 min.): Same measurements and procedures as at visit 1 and 2 except for CPET.\n\nTelephone 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.\n\nTelephone follow-up and questionnaire 5 years after CR (approx. 15 min.): Same interview and questionnaire as at 3-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in an ambulatory CR program (all age groups)\n* Written informed consent\n\nExclusion Criteria:\n\n* Inability to follow an ambulatory CR program more than 3 weeks\n* Not willing to give informed consent\n* Inability to understand the informed consent due to language comprehension\n* Lack of discernment'}, 'identificationModule': {'nctId': 'NCT05500859', 'acronym': 'SwissPR', 'briefTitle': 'Swiss Secondary Prevention and Rehabilitation Registry', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Swiss Secondary Prevention and Rehabilitation Registry: SwissPR', 'orgStudyIdInfo': {'id': '2019-02057; me19Pfister'}}, 'armsInterventionsModule': {'interventions': [{'name': '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', 'type': 'OTHER', 'description': '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)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Otmar Pfister, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'otmar.pfister@usb.ch', 'phone': '+41 61 328 7482'}, {'name': 'Otmar Pfister, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Basel, Division of Outpatient Cardiology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Otmar Pfister, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'otmar.pfister@usb.ch', 'phone': '+41 61 328 7482'}, {'name': 'Steffen Biniasch', 'role': 'CONTACT', 'email': 'steffen.biniasch@usb.ch'}], 'overallOfficials': [{'name': 'Otmar Pfister, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Outpatient Cardiology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}