Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-27 @ 2:56 PM
Study NCT ID:
NCT07181356
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients diagnosed with acute myocardial infarction on admission were immediately assigned to the experimental group and control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2146}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of MACCEs', 'timeFrame': '12 months after discharge', 'description': 'MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke, admission due to heart failure )'}], 'secondaryOutcomes': [{'measure': 'Rate of Cardiovascular death events', 'timeFrame': '12 months after discharge', 'description': 'Rate of Cardiovascular death events'}, {'measure': 'Rate of non-fatal acute myocardial infarction events', 'timeFrame': '12 months after discharge', 'description': 'Rate of non-fatal acute myocardial infarction events'}, {'measure': 'Rate of revascularization events', 'timeFrame': '12 months after discharge', 'description': 'Rate of revascularization events'}, {'measure': 'Rate of stroke events', 'timeFrame': '12 months after discharge', 'description': 'Rate of stroke events'}, {'measure': 'Rate of admission due to heart failure events', 'timeFrame': '12 months after discharge', 'description': 'Rate of admission due to heart failure events'}, {'measure': 'Rate of all all-cause death events', 'timeFrame': '12 months after discharge', 'description': 'Rate of all all-cause death events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'At present, there are 290 million cardiovascular patients in China, including 11 million patients with coronary heart disease. Remote ischemic preconditioning(RIPC) may play an effective endogenous cardiac protection.This study will explore whether long-term use of RIPC in patients with AMI after PCI and non interventional therapy can reduce the incidence of major adverse cardiovascular cerebrovascular events(MACCE) and improve clinical outcomes and long-term prognosis.', 'detailedDescription': 'A total of 2146 patients with AMI are expected included as the research objects and randomly divided into experimental group and control group with 1073 cases in each group. After admission, Patients in the experimental group received everyday RIPC of upper limbs to the end of follow-up.The control group is a blank control and undergoes conventional medical procedures. Routine blood indexes, ultrasound, electrocardiogram, were detected On the day of admission. 12 months post- discharge, the incidence of MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, stent thrombosis, revascularization, stroke, admission due to heart failure and the above composite events were independent components) and Poce(All deaths, all strokes, all myocardial infarction, or all revascularization events)will recorded by telephone follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute myocardial infarction were diagnosed in accordance with the criteria of the "Global Unified Definition of Fourth Myocardial Infarction"\n\nExclusion Criteria:\n\n* The patients could not tolerate RIPC or RIPerC\n* Aortic dissection, coronary artery aneurysm, coronary artery fistula and other systemic organic diseases\n* The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively\n* severe liver dysfunction (bilirubin \\> 20 mmol / L, prothrombin time \\> 2.0 ratio)\n* Severe renal insufficiency (GFR \\< 30 ml / min / 1.73 m2);\n* patients taking nicorandil and other drugs affecting microcirculation\n* pregnant'}, 'identificationModule': {'nctId': 'NCT07181356', 'acronym': 'L-RICP-AMI', 'briefTitle': 'Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Henan Institute of Cardiovascular Epidemiology'}, 'officialTitle': 'Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'HenanICE202105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group1（RIPerC+RIPC）', 'description': 'Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction， and Remote ischemic PREconditioning was performed daily after discharge', 'interventionNames': ['Other: RIPerC', 'Other: RIPC']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group2（RIPerC）', 'description': 'Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction', 'interventionNames': ['Other: RIPerC']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'A group of patients who received conventional treatment without any additional intervention'}], 'interventions': [{'name': 'RIPerC', 'type': 'OTHER', 'description': 'Each 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles', 'armGroupLabels': ['Experimental Group1（RIPerC+RIPC）', 'Experimental Group2（RIPerC）']}, {'name': 'RIPC', 'type': 'OTHER', 'description': 'Each 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles', 'armGroupLabels': ['Experimental Group1（RIPerC+RIPC）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'GUO QUAN', 'role': 'CONTACT', 'email': 'xinyiguoquan@163.com', 'phone': '15670510031'}, {'name': 'Muwei LI', 'role': 'CONTACT', 'email': 'lmw0207@163.com', 'phone': '13838083966'}], 'facility': 'Fuwai Central China Cardiovascular Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Muwei LI', 'role': 'CONTACT', 'email': 'lmw0207@163.com', 'phone': '13838083966'}, {'name': 'GUO QUAN', 'role': 'CONTACT', 'email': 'xinyiguoquan@163.com', 'phone': '15670510031'}], 'overallOfficials': [{'name': 'Muwei LI, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai Central China of Cardiovascular Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Institute of Cardiovascular Epidemiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}