Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03614559
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-11', 'studyFirstSubmitDate': '2018-07-29', 'studyFirstSubmitQcDate': '2018-07-29', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of major adverse cardiac and cerebrovascular events (MACCE）', 'timeFrame': '2 years after CAG', 'description': 'MACCE, including any of the following adverse events before hospital discharge: death from any cause, Q-wave myocardial infarction, recurrent symptoms Heart and Vessels requiring urgent repeat target vessel revascularization with PCI or CABG, tamponade requiring either pericardiocentesis or surgery, and stroke.'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessment', 'timeFrame': '2 years after CAG', 'description': 'Two years after having CAG ， we may talk to patient face to face or by phone to help them finish the Seattle Angina Questionnaire （SAQ），measure the score of SAQ and assess the quality of life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic total occlusion'], 'conditions': ['Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'In order to know more about contemporary clinical treatment ,epidemiological characteristics, and long-term outcomes in patients with Coronary Chronic Total Occlusion（CTO）in China, the study through collecting and effective analyzing basic information, cardiovascular characteristics, contemporary clinical treatment , and long-term outcomes of CTO patients ,to describe the relevant risk factors ,the contemporary incidence of CTOs and the success rates of CTO percutaneous coronary intervention (PCI), as well as the complications and long-term outcomes of these patients, to explore the relevant factors which affecting the success rates of PCI therapy and to provide safer and more effective advice for the treatment of CTO.', 'detailedDescription': 'Study Center : Shanghai Zhongshan Hospital\n\nStudy Purpose : Through collecting and effective analyzing basic information, cardiovascular characteristics, contemporary clinical treatment , and long-term outcomes of CTO patients ,to describe the relevant risk factors ,the contemporary incidence of CTOs and the success rates of CTO percutaneous coronary intervention (PCI), as well as the complications and long-term outcomes of these patients, to explore the relevant factors which affecting the success rates of PCI therapy and to provide safer and more effective advice for the treatment of CTO.\n\nStudy Design : A Retrospective Observational Study\n\nStudy Population Description : All CTO patients who has been diagnosed by coronary angiography in Shanghai Zhongshan Hospital in 2016-08-01 to 2020-12-31\n\nEligibility Criteria :\n\nEntry Criteria :\n\n1. Age ≥17 years old;\n2. Finished coronary angiography(CAG) in Shanghai Zhongshan Hospital;\n3. CAG found coronary artery(-ies) was/were total occluded more than 3 months;\n4. CAG found the diameter of total occluded coronary artery was more than 2.5cm;\n\nExclude Criteria:\n\n1. Cardiac arrest; Ventricular fibrillation; Cardiogenic shock; Acute thrombosis in the stent; Acute coronary syndrome;\n2. The bridge vessel(-s) was/were not total occluded and coronary artery(-ies) was/were total occluded but not trying to revascularize in CAG of the patient who has gone through coronary artery bypass graft before;\n3. The diameter was too small or position was too distal of the total occluded coronary artery;\n4. Combined severe hepatic or renal insufficiency;\n5. The patient who has history of major surgical, cerebral hemorrhage, severe gastrointestinal bleeding, severe anemia, severe allergies, and other anti-platelet drug contraindications in recent 3 months;\n6. Pregnant, lactating women;\n7. Suffer from malignant tumor or life expectancy less than 2 years\n\nSample size :\n\nCollecting all cases of CTO patient who has been diagnosed in 2016-08-01 to 2020-12-31 and comply with entry and exclude standards, the expectation of quantity is about 3000-4000.\n\nFollow up time： 2 years\n\nInformation collection:\n\n1. Basic information: name, gender, age, hospital number, contact information;\n2. Relevant risk factors: medication history, smoking history, drinking history, history of hypertension, history of diabetes, history of dyslipidemia, history of arrhythmia, history of cerebrovascular disease, history of renal insufficiency, previous coronary CTA, and previous myocardial infarction, previous PCI and time, previous CABG surgery and time;\n3. Cardiovascular information: Preoperative and postoperative BNP, preoperative and postoperative cTnT, cardiac ultrasonography and LVEF, total occluded coronary artery, collateral circulation establishment, J-CTO score, Progress score, PCI operation mode, contrast agent usage, and final treatment plan;\n4. Follow-up content: short-term results (perioperative-related complications) and 2-year long-term results (cardiac and LVEF, cardiac death, re-hospitalization of acute myocardial infarction, and subsequent CABG surgery)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All CTO patients who has been diagnosed by coronary angiography in Shanghai Zhongshan Hospital in 2016-08-01 to 2017-07-31.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Entry Criteria :\n\n1. Age ≥18 years old;\n2. Finished coronary angiography(CAG) in Shanghai Zhongshan Hospital in 2016-08-01 to 2017-07-31;\n3. CAG found coronary artery(-ies) was/were total occluded more than 3 months;\n4. CAG found the diameter of total occluded coronary artery was more than 2.5cm;\n\nExclude Criteria:\n\n1. Cardiac arrest; Ventricular fibrillation; Cardiogenic shock; Acute thrombosis in the stent; Acute coronary syndrome;\n2. The bridge vessel(-s) was/were not total occluded and coronary artery(-ies) was/were total occluded but not trying to revascularize in CAG of the patient who has gone through coronary artery bypass graft before;\n3. The diameter was too small or position was too distal of the total occluded coronary artery;\n4. Combined severe hepatic or renal insufficiency;\n5. The patient who has history of major surgical, cerebral hemorrhage, severe gastrointestinal bleeding, severe anemia, severe allergies, and other anti-platelet drug contraindications in recent 3 months;\n6. Pregnant, lactating women;\n7. Suffer from malignant tumor or life expectancy less than 2 years'}, 'identificationModule': {'nctId': 'NCT03614559', 'acronym': 'PCI', 'briefTitle': 'Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion："Time" is the Success Rate of PCI', 'orgStudyIdInfo': {'id': 'ZS-FDU-20180501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CTO PCI group and non CTO PCI group', 'description': 'CTO PCI group： Succession of CTO revascularization non CTO PCI group： Failure or not tried to revascularization'}, {'label': 'Initially attempted and re-attempted', 'description': 'PCI initially attempted group： First time to try to revascularization PCI re-attempted group: Second or more time to try to revascularization'}, {'label': 'PCI during China Club or not', 'description': 'PCI during Chronic Total Occlusion Club， China Club : CAG in 2016.11.04 Another group: CAG in other time'}, {'label': 'Morning，Afternoon，Night', 'description': 'Morning group:（8:00-12:59） Afternoon group：（13:00-17:59） Night group：（after 18:00）'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Chen, Bachelor', 'role': 'CONTACT', 'email': 'chen.lu1@zs-hospital.sh.cn', 'phone': '18321122021', 'phoneExt': '18321122021'}, {'name': 'Hao Cheng, Bachelor', 'role': 'CONTACT', 'phone': '15221113091'}, {'name': 'Junbo Ge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jianying Ma, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lu Chen, Bachelor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hao Cheng, Bachelor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lu Chen', 'role': 'CONTACT', 'email': 'chen.lu1@zs-hospital.sh.cn', 'phone': '18321122021', 'phoneExt': '18321122021'}, {'name': 'Hao Cheng', 'role': 'CONTACT', 'phone': '15221113091'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Junbo Ge', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}