Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-05 @ 1:29 AM
Study NCT ID:
NCT05614050
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2022-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognosis of Patients After PCI：a Multi-center Study in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma and whole blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-22', 'studyFirstSubmitDate': '2022-11-06', 'studyFirstSubmitQcDate': '2022-11-06', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '12 months', 'description': 'A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization'}], 'secondaryOutcomes': [{'measure': 'all-cause death', 'timeFrame': '12 months', 'description': 'Occurrence of all-cause death'}, {'measure': 'cardiovascular death', 'timeFrame': '12 months', 'description': 'Occurrence of cardiovascular death'}, {'measure': 'nonfatal myocardial infarction', 'timeFrame': '12 months', 'description': 'Occurrence of nonfatal myocardial infarction'}, {'measure': 'nonfatal stroke', 'timeFrame': '12 months', 'description': 'Occurrence of of nonfatal stroke'}, {'measure': 'ischemia-driven revascularization', 'timeFrame': '12 months', 'description': 'Occurrence of ischemia-driven revascularization'}, {'measure': 'hospitalization for unstable angina', 'timeFrame': '12 months', 'description': 'Occurrence of hospitalization for unstable angina'}, {'measure': 'stent/scaffold thrombosis', 'timeFrame': '12 months', 'description': 'Occurrence of stent/scaffold thrombosis'}, {'measure': 'in-stent restenosis', 'timeFrame': '12 months', 'description': 'Occurrence of in-stent restenosis'}, {'measure': 'bleeding', 'timeFrame': '12 months', 'description': 'Occurrence of bleeding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'Coronary artery disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular and cerebrovascular events (MACCE). At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Previous studies indicated that hsCRP ≥ 2mg / L was the definition standard of RIR in CAD in European and American people. In China, the impact of dynamic changes of hsCRP and other inflammatory factors on MACCE in PCI population remains unclear. Therefore, in this study, the investigators plan to recruit patients undergoing PCI, and observe the impact of hsCRP and other inflammatory factors on the prognosis of these patients during long term follow-up at 17 hospitals in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The hospitalized patients with coronary heart disease completing all planned PCI', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who understand and sign the informed consent voluntarily;\n* Age ≥ 18 years old and ≤ 80 years old, regardless of sex;\n* The hospitalized patients with coronary heart disease undergoing PCI;\n* Complete all planned PCI during hospitalization.\n\nExclusion Criteria:\n\n* Acute, chronic or recurrent infectious diseases;\n* Immune diseases or immune-related diseases;\n* Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapy drugs;\n* Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive measures;\n* The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.'}, 'identificationModule': {'nctId': 'NCT05614050', 'briefTitle': 'The Prognosis of Patients After PCI：a Multi-center Study in China', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'The Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study in China', 'orgStudyIdInfo': {'id': 'ChiPCI'}}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Cheng, Doctor', 'role': 'CONTACT', 'email': 'nathancx@hust.edu.cn', 'phone': '+8602785726011'}, {'name': 'Xiang Cheng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Miao Yu', 'role': 'CONTACT', 'email': 'yumiaodavid@126.com', 'phone': '+862785726009'}], 'overallOfficials': [{'name': 'Xiang Cheng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Shanxi Cardiovascular Hospital', 'class': 'OTHER'}, {'name': "First People's Hospital of Xianyang", 'class': 'OTHER'}, {'name': "Yichang Central People's Hospital", 'class': 'OTHER'}, {'name': 'Jingzhou Central Hospital', 'class': 'OTHER'}, {'name': 'The First Hospital of Wuhan', 'class': 'UNKNOWN'}, {'name': 'Wuhan Central Hospital', 'class': 'OTHER'}, {'name': 'Wuhan Fourth Hospital', 'class': 'UNKNOWN'}, {'name': 'Fifth Hospital in Wuhan', 'class': 'UNKNOWN'}, {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'Central Hospital of Enshi Tujia and Miao Autonomous Prefecture', 'class': 'UNKNOWN'}, {'name': 'Hubei University of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'investigatorFullName': 'Xiang Cheng', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}