Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT05175495
Status:
UNKNOWN
Last Update Posted:
2023-07-25
First Post:
2021-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influencing Factors of Coronary Heart Disease in Young People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood、serum、plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-23', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-12-27', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whether inflammatory factors are differentially expressed in young patients with coronary heart disease', 'timeFrame': 'Until April 2024', 'description': 'The Investigators will analyze blood samples from the participants to see if there was a difference in the expression of inflammatory factors with high correlation compared with the control group by ELESA and High-throughput sequencing.'}, {'measure': 'The effect of gene activity on youth morbidity', 'timeFrame': 'Until April 2024', 'description': 'The investigators will use enrichment analysis to screen the target genes and sequence the participants.Whether the target gene was expressed at high levels in the participants.And the investigators will further analyze the target gene'}, {'measure': 'Sedentary, high-fat diet, lack of exercise and other unhealthy lifestyle effects on young people', 'timeFrame': 'Until April 2024', 'description': "The researchers will retrospectively examine the participants' negative lifestyle habits, such as sedentary behavior, smoking, high-fat diet, and lack of exercise, in combination with their coronary angiography results"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary heart disease', 'Inflammatory cytokines', 'lifestyle', 'Familial inheritance', 'Myocardial infarction'], 'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'The incidence of coronary heart disease in young people is not uncommon and the investigators will explore the factors contributing to this outcome', 'detailedDescription': "Through the multi-center clinical research conducted by several units in Nantong city, the risk factors and aggregation of the incidence of CHD among young people in nantong city were obtained, so as to fill in the blank of domestic multi-center research and reduce the incidence of CHD among young people.The investigators will conduct a long-term follow-up study on the young patients with CHD to screen the factors contributing to the poor prognosis of CHD in young patients.The investigators will fill this gap and intervene early to improve patients' quality of life and prolong their survival"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed coronary heart disease', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed coronary heart disease\n* Confirmed by coronary angiography\n* Diagnosed myocardial infarction\n* Willing to sign an inform consent\n\nExclusion Criteria:\n\n* Patients won't sign an inform consent or will not comply with the follow up."}, 'identificationModule': {'nctId': 'NCT05175495', 'briefTitle': 'Influencing Factors of Coronary Heart Disease in Young People', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Nantong University'}, 'officialTitle': 'To Study the Risk Factors of Youth Coronary Heart Disease From Inflammatory Cytokines，Lifestyle and Familial Inheritance', 'orgStudyIdInfo': {'id': 'Observational'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal young', 'description': 'Aged less than 45 years old,no underlying heart disease'}, {'label': 'Young people diagnosed with coronary heart disease', 'description': 'Aged less than 45 years old,Diagnosed coronary heart disease;Confirmed by coronary angiography;Diagnosed myocardial infarction;Typical symptom of ischemic chest pain with positive stress test;'}, {'label': 'Coronary heart disease', 'description': 'Older than 65 years, diagnosed with coronary heart disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '226000', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'HZ S, Dr.', 'role': 'CONTACT', 'email': 'yjshz@ntu.edu.cn', 'phone': '13515203348'}, {'name': "H L, A master's degree", 'role': 'CONTACT', 'email': '898571711@qq.com', 'phone': '18351328050'}], 'facility': 'shengHz', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}], 'centralContacts': [{'name': 'hzh sheng, Dr.', 'role': 'CONTACT', 'email': 'yjshz@ntu.edu.cn', 'phone': '13515203348'}, {'name': "H L, A master's degree", 'role': 'CONTACT', 'email': '898571711@qq.com', 'phone': '18351328050'}], 'overallOfficials': [{'name': 'hzh sheng, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Affiliated Hospital of Nantong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will share our findings with you when the 2024 project is due'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongzhuan Sheng', 'class': 'OTHER'}, 'collaborators': [{'name': 'Affiliated Hospital of Nantong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Hongzhuan Sheng', 'investigatorAffiliation': 'Affiliated Hospital of Nantong University'}}}}