Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT05808751
Status:
UNKNOWN
Last Update Posted:
2023-04-11
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Cardiac Rehabilitation Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2081}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause and attributed deaths', 'timeFrame': '1-year and 2-year', 'description': 'All-cause and attributed deaths during hospitalization and follow-up of CVD patients'}, {'measure': 'Major adverse cardiovascular events (MACE) occurrence', 'timeFrame': '1-year and 2-year', 'description': 'Major adverse cardiovascular events (MACE) occurrence include cardiovascular death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemia-driven revascularization.'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary function and quality of life', 'timeFrame': '1-year and 2-year', 'description': 'Cardiopulmonary function and quality of life in cardiac rehabilitation patients during the follow-up period'}, {'measure': 'Participation and adherence', 'timeFrame': '1-year and 2-year', 'description': 'Participation and adherence in outpatient cardiac rehabilitation.'}, {'measure': 'Medical costs of cardiac rehabilitation patients during hospitalization and up to 2 years after discharge.', 'timeFrame': '1-year and 2-year', 'description': 'Medical costs of cardiac rehabilitation patients during hospitalization and up to 2 years after discharge.'}, {'measure': 'Proportion of different comorbidities, interactions and prognosis in CVD.', 'timeFrame': '1-year and 2-year', 'description': 'Proportion of different comorbidities, interactions and prognosis in CVD.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': 'Establish an electronic cardiac rehabilitation patient registration system and clinical database, carry out prospective cohort follow-up and observation of cardiovascular disease (CVD) patients receiving cardiac rehabilitation in inpatients and outpatients, collect risk factors, diagnosis and treatment status, rehabilitation diagnosis and treatment, clinical outcomes and follow-up results, and establish a short-term and long-term follow-up mechanism.', 'detailedDescription': 'Establish an electronic cardiac rehabilitation patient registration system and clinical database, carry out prospective cohort follow-up and observation of cardiovascular disease (CVD) patients receiving cardiac rehabilitation in inpatients and outpatients, collect risk factors, diagnosis and treatment status, rehabilitation diagnosis and treatment, clinical outcomes and follow-up results, and establish a short-term and long-term follow-up mechanism. Through the real world clinical practice data of cardiac rehabilitation of CVD patients, describe the population and disease characteristics of cardiac rehabilitation patients, the provision of cardiac rehabilitation services and the influencing factors; Analyze and study the key technologies of clinical cardiac rehabilitation, evaluate the implementation quality of cardiac rehabilitation, improve the clinical pathway of cardiac rehabilitation, and optimize the service process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CVD who received inpatient cardiac rehabilitation at Fu Wai Hospital and those who participated in outpatient cardiac rehabilitation at the Cardiac Rehabilitation Center of Fu Wai Hospital after discharge from the hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age and older.\n2. Patients receiving inpatient cardiac rehabilitation, and/or participating in outpatient cardiac rehabilitation.\n3. All cases selected were in New York Heart Association (NYHA) cardiac function class II and below.\n4. Normal troponin.\n5. Patients with some ability to communicate and understand.\n6. have signed an informed consent form. -\n\nExclusion Criteria:\n\n1. Subjects who are participating in clinical trials of other drugs or devices.\n2. Patients with NYHA cardiac function class III or higher.\n3. Mentally impaired, or unable to communicate effectively with investigators.\n4. Refusal to sign the informed consent form.'}, 'identificationModule': {'nctId': 'NCT05808751', 'briefTitle': 'Clinical Cardiac Rehabilitation Registry Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Clinical Cardiac Rehabilitation Registry Study', 'orgStudyIdInfo': {'id': '2022-1785'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xue Feng, PhD', 'role': 'CONTACT', 'email': 'hlmc@fuwai.com', 'phone': '010-88396087'}, {'name': 'Yifan Wu, MD', 'role': 'CONTACT', 'email': 'wuyifan1127@126.com', 'phone': '18811590150'}], 'overallOfficials': [{'name': 'Xue Feng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}