Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-11 @ 5:39 PM
Study NCT ID:
NCT03102502
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood flow velocity', 'timeFrame': 'At baseline, during EECP and week 7 (post intervention)', 'description': 'Change from baseline in blood flow velocity measured by color Doppler ultrasound system'}], 'secondaryOutcomes': [{'measure': 'Change in vascular endothelial function', 'timeFrame': 'At baseline and week 7 (post intervention)', 'description': 'Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system'}, {'measure': 'Change in atherosclerosis', 'timeFrame': 'At baseline and week 7 (post intervention)', 'description': 'Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Heart Disease', 'Atherosclerosis', 'Vascular Endothelium', 'Counterpulsation, External'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '17936150', 'type': 'BACKGROUND', 'citation': 'Manchanda A, Soran O. Enhanced external counterpulsation and future directions: step beyond medical management for patients with angina and heart failure. J Am Coll Cardiol. 2007 Oct 16;50(16):1523-31. doi: 10.1016/j.jacc.2007.07.024. Epub 2007 Oct 1.'}, {'pmid': '16979007', 'type': 'BACKGROUND', 'citation': 'Nichols WW, Estrada JC, Braith RW, Owens K, Conti CR. Enhanced external counterpulsation treatment improves arterial wall properties and wave reflection characteristics in patients with refractory angina. J Am Coll Cardiol. 2006 Sep 19;48(6):1208-14. doi: 10.1016/j.jacc.2006.04.094. Epub 2006 Aug 28.'}, {'pmid': '20921442', 'type': 'BACKGROUND', 'citation': 'Braith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.'}, {'pmid': '17620513', 'type': 'BACKGROUND', 'citation': 'Zhang Y, He X, Chen X, Ma H, Liu D, Luo J, Du Z, Jin Y, Xiong Y, He J, Fang D, Wang K, Lawson WE, Hui JC, Zheng Z, Wu G. Enhanced external counterpulsation inhibits intimal hyperplasia by modifying shear stress responsive gene expression in hypercholesterolemic pigs. Circulation. 2007 Jul 31;116(5):526-34. doi: 10.1161/CIRCULATIONAHA.106.647248. Epub 2007 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms', 'detailedDescription': 'Patients with coronary heart disease will be randomized into two groups: standard medical treatment and standard medical treatment plus EECP intervention. Hemodynamic parameters, vascular status and function will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography\n* Or history of myocardial infarction\n* Or history of prior revascularization\n* Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Clinically significant valvular heart disease\n* Aortic aneurysm\n* Congenital heart disease\n* Acute myocarditis\n* Arrythmias significantly interfere with the triggering of the EECP device\n* History of cerebral hemorrhage\n* Hemorrhagic disease\n* Lower limb infection, phlebitis\n* Deep venous thrombosis\n* Malignant disease\n* INR \\> 2.5\n* Uncontrolled hypertension, defined as SBP \\> 180mmHg or DBP \\> 110mmHg\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03102502', 'acronym': 'EECPVHS', 'briefTitle': 'Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status', 'orgStudyIdInfo': {'id': 'EECP- 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced External Counterpulsation', 'description': 'Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period.', 'interventionNames': ['Device: EECP', 'Drug: Medical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.', 'interventionNames': ['Drug: Medical therapy']}], 'interventions': [{'name': 'EECP', 'type': 'DEVICE', 'otherNames': ['Enhanced External Counterpulsation'], 'description': 'Enhanced external counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.', 'armGroupLabels': ['Enhanced External Counterpulsation']}, {'name': 'Medical therapy', 'type': 'DRUG', 'otherNames': ['Guideline- driven medical therapy'], 'description': 'Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）', 'armGroupLabels': ['Control', 'Enhanced External Counterpulsation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat- sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yan Zhang, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}, {'name': 'Zhensheng Zheng, M. D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yan Zhang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}