Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-02 @ 12:03 PM
Study NCT ID:
NCT07130968
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-09
First Post:
2025-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Cohort Study of Cardiopulmonary Function in Chinese Patients With Cardiovascular Disease: CPET Evaluation and Five-Year Prognostic Follow-Up Based on a Multicenter Structured Data Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2035-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence rate of adverse events during exercise', 'timeFrame': 'During each exercise session and within 24 hours after exercise'}], 'primaryOutcomes': [{'measure': 'Characteristics of CPET parameters across different cardiovascular diseases.', 'timeFrame': 'After enrollment', 'description': 'Cardiopulmonary exercise testing (CPET) was performed using exercise cardiopulmonary testing systems from VYAIRE (Germany) and SCHILLER (Switzerland). A symptom-limited maximal exercise test with a 1-minute ramp incremental protocol (Ramp protocol) was adopted, designed to complete the workload test within 8-12 minutes according to the incremental power calculation formula.\n\nThe incremental workload was calculated as follows:\n\nUnloaded VO₂ (ml/min) per minute = 150 + (6 × body weight) Predicted peak VO₂max (ml/min) per minute for males = (height in cm - age in years) × 20 Predicted peak VO₂max (ml/min) per minute for females = (height in cm - age in years) × 14 Incremental power per minute = (predicted peak VO₂max - unloaded VO₂)/100\n\nDuring exercise, real-time cardiopulmonary parameters were collected, including peak oxygen uptake (VO₂peak), anaerobic threshold (AT), maximal cycling workload, respiratory rate, minute ventilation (VE), and ventilatory efficiency, among others.'}, {'measure': 'Incidence of 5-year MACE', 'timeFrame': 'from enrollment to 5 years post-enrollment', 'description': 'MACE (cardiovascular death, unplanned repeat revascularization, cardiac rehospitalization, non-fatal myocardial infarction, stroke)'}], 'secondaryOutcomes': [{'measure': 'Incidence of individual events of MACE per year (incidence of cardiac death, unplanned rereconstitution, cardiac rehospitalization, nonfatal myocardial infarction, and stroke)', 'timeFrame': 'yearly for 5 years (Year 1/2/3/4/5 from enrollment)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary Exercise Testing', 'Cardiovascular Diseases', 'Major Adverse Cardiovascular Events (MACE)', 'Prognosis', 'Exercise Capacity', 'Cardiorespiratory Fitness', 'Clinical Outcomes', 'Real-world Study'], 'conditions': ['MACE', 'Cardiac Death', 'Unplanned Repeat Revascularization', 'Cardiac Rehospitalization', 'Non-fatal Myocardial Infarction', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '10027821', 'type': 'RESULT', 'citation': 'Shephard RJ, Balady GJ. Exercise as cardiovascular therapy. Circulation. 1999 Feb 23;99(7):963-72. doi: 10.1161/01.cir.99.7.963. No abstract available.'}, {'pmid': '30115967', 'type': 'RESULT', 'citation': 'Fiuza-Luces C, Santos-Lozano A, Joyner M, Carrera-Bastos P, Picazo O, Zugaza JL, Izquierdo M, Ruilope LM, Lucia A. Exercise benefits in cardiovascular disease: beyond attenuation of traditional risk factors. Nat Rev Cardiol. 2018 Dec;15(12):731-743. doi: 10.1038/s41569-018-0065-1.'}, {'pmid': '31891317', 'type': 'RESULT', 'citation': 'DeCato TW, Haverkamp H, Hegewald MJ. Cardiopulmonary Exercise Testing (CPET). Am J Respir Crit Care Med. 2020 Jan 1;201(1):P1-P2. doi: 10.1164/rccm.2011P1. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/30115967/', 'label': 'websites associated with the cited references'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to observe the characteristics of cardiopulmonary exercise testing (CPET) parameters in patients across different cardiovascular diseases and to evaluate the predictive value of multiparameter cardiopulmonary indices for 5-year major adverse cardiovascular events (MACE).', 'detailedDescription': 'To investigate the CPET characteristics in patients with various cardiovascular diseases (including acute myocardial infarction, heart failure, cardiomyopathy, valvular heart disease, coronary artery disease, and perioperative cardiac surgery), with annual follow-up of major adverse cardiovascular events (MACE) for five years, and to establish the predictive value of combined CPET parameters for MACE in this population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'China CardioVascular Disease Patient and healthy control group', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-80 years,\n2. Ability to comprehend and provide written informed consent.\n\nExclusion Criteria:\n\n1. Comorbid severe conditions (e.g., recent acute myocardial infarction, unstable angina, uncontrolled arrhythmias, severe aortic coarctation or descending aortic aneurysm, acute myocarditis or pericarditis, acute congestive heart failure, acute respiratory failure, resting oxygen saturation \\<93%, recent arterial or pulmonary embolism, pulmonary edema).\n2. Conditions potentially exacerbated by exercise (e.g., acute cardiac insufficiency, exercise-induced asthma, epilepsy).\n3. Physical disability due to musculoskeletal or neuromuscular disorders.\n4. Pregnancy or lactation.\n5. Patients deemed unsuitable for participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT07130968', 'acronym': 'China-CPET', 'briefTitle': 'Real-World Cohort Study of Cardiopulmonary Function in Chinese Patients With Cardiovascular Disease: CPET Evaluation and Five-Year Prognostic Follow-Up Based on a Multicenter Structured Data Platform', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Real-World Cohort Study of Cardiopulmonary Function in Chinese Patients With Cardiovascular Disease: CPET Evaluation and Five-Year Prognostic Follow-Up Based on a Multicenter Structured Data Platform', 'orgStudyIdInfo': {'id': 'KY2025-499-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cardiovascular disease patient with MACE', 'description': 'cardiovascular disease patient with MACE（Cardiac death, unplanned revascularization, cardiac readmission, non-fatal myocardial infarction, and stroke）'}, {'label': 'cardiovascular disease patient without MACE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Yuebei People's Hospital", 'class': 'OTHER'}, {'name': "People's Hospital of Xinjiang Uygur Autonomous Region", 'class': 'OTHER'}, {'name': 'Gansu Provincial Hospital', 'class': 'OTHER'}, {'name': 'Shenzhen Center for Chronic Disease Control', 'class': 'OTHER'}, {'name': "Yangjiang People's Hospital", 'class': 'OTHER'}, {'name': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Qingdao Municipal Hospital', 'class': 'OTHER'}, {'name': "Weifang People's Hospital", 'class': 'OTHER'}, {'name': "Guangming District People's Hospital of Shenzhen", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation', 'investigatorFullName': 'Huan Ma', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}