Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-27 @ 11:42 AM
Study NCT ID:
NCT01198405
Status:
UNKNOWN
Last Update Posted:
2010-09-10
First Post:
2010-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1050}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-09', 'studyFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction', 'timeFrame': 'up to 5 years'}], 'secondaryOutcomes': [{'measure': 'vascular endothelial function', 'timeFrame': 'up to 5 years', 'description': 'measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)'}, {'measure': 'cardiac structure and exercise tolerance', 'timeFrame': 'up to 5 years', 'description': "cardiac chamber diameter, left ventricular wall thickness, ejection fraction, and etc., as deternmined by echocardiographic examination; exercise tolerance, as determined by Treadmill's Test"}, {'measure': 'new-onset diabetes', 'timeFrame': 'up to 5 years', 'description': 'fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)'}, {'measure': 'atherosclerosis', 'timeFrame': 'up to 5 years', 'description': 'peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP \\& DBP)'}, {'measure': '24-hour urinary protein', 'timeFrame': 'up to 5 years', 'description': '24-hour urinary protein/albumin by urinalysis'}, {'measure': 'all-cause mortality', 'timeFrame': 'up to 5 years'}, {'measure': 'revascularization rate', 'timeFrame': 'up to 5 years'}, {'measure': 'rehospitalization rate', 'timeFrame': 'up to 5 years'}, {'measure': 'rate of acute myocardial infarction', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'enhanced external counterpulsation'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '18404725', 'type': 'BACKGROUND', 'citation': 'Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.'}, {'pmid': '20458834', 'type': 'BACKGROUND', 'citation': 'Kitsou V, Xanthos T, Roberts R, Karlis GM, Padadimitriou L. Enhanced external counterpulsation: mechanisms of action and clinical applications. Acta Cardiol. 2010 Apr;65(2):239-47. doi: 10.2143/AC.65.2.2047060.'}, {'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': '17063167', 'type': 'BACKGROUND', 'citation': 'Michaels AD, McCullough PA, Soran OZ, Lawson WE, Barsness GW, Henry TD, Linnemeier G, Ochoa A, Kelsey SF, Kennard ED. Primer: practical approach to the selection of patients for and application of EECP. Nat Clin Pract Cardiovasc Med. 2006 Nov;3(11):623-32. doi: 10.1038/ncpcardio0691.'}, {'pmid': '17046434', 'type': 'BACKGROUND', 'citation': 'Cohn PF. Enhanced external counterpulsation for the treatment of angina pectoris. Prog Cardiovasc Dis. 2006 Sep-Oct;49(2):88-97. doi: 10.1016/j.pcad.2006.04.001.'}, {'pmid': '16979008', 'type': 'BACKGROUND', 'citation': "O'Rourke MF, Hashimoto J. Enhanced external counterpulsation why the benefit? J Am Coll Cardiol. 2006 Sep 19;48(6):1215-6. doi: 10.1016/j.jacc.2006.06.036. Epub 2006 Aug 28. No abstract available."}, {'pmid': '16291000', 'type': 'BACKGROUND', 'citation': 'Michaels AD, Raisinghani A, Soran O, de Lame PA, Lemaire ML, Kligfield P, Watson DD, Conti CR, Beller G. The effects of enhanced external counterpulsation on myocardial perfusion in patients with stable angina: a multicenter radionuclide study. Am Heart J. 2005 Nov;150(5):1066-73. doi: 10.1016/j.ahj.2005.01.054.'}, {'pmid': '11813825', 'type': 'BACKGROUND', 'citation': 'Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto R, Ferrans CE, Keller S. Effects of enhanced external counterpulsation on Health-Related Quality of Life continue 12 months after treatment: a substudy of the Multicenter Study of Enhanced External Counterpulsation. J Investig Med. 2002 Jan;50(1):25-32. doi: 10.2310/6650.2002.33514.'}, {'pmid': '10362181', 'type': 'BACKGROUND', 'citation': 'Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least one coronary lesion of more than 50% stenosis shown by angiography\n* history of acute myocardial infarction(at least one month before)\n* history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting)\n* typical angina episodes with evidence of myocardial ischemia\n* Signed informed consent\n\nExclusion Criteria:\n\n* Obvious aortic insufficiency, aortic aneurysm, aortic dissection\n* Coronary fistula or severe coronary aneurysm\n* Symptomatic Congestive heart failure\n* Valvular heart disease, congenital heart diseases, cardiomyopathies\n* Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency;\n* Lower limb infection, phlebitis, varicosity, deep venous thrombosis;\n* Progressive malignancies or diseases with poor prognosis;\n* uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg'}, 'identificationModule': {'nctId': 'NCT01198405', 'acronym': 'PROBE-EECP', 'briefTitle': 'Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'SYSU-5010-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced External Counterpulsation', 'description': 'Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.', 'interventionNames': ['Device: Enhanced external counterpulsation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Guideline-driven standard medical therapy.', 'interventionNames': ['Drug: Guideline-driven standard medical therapy']}], 'interventions': [{'name': 'Enhanced external counterpulsation', 'type': 'DEVICE', 'description': 'Treatment of enhanced external counterpulsation (EECP) with a prespecified protocol on top of a guideline-driven standard medical therapy. EECP Protocol is defined as a standard session of a total of 36 hours of EECP treatment, given one hour per day, six days per week. The same session is thereafter repeated at least once every year.', 'armGroupLabels': ['Enhanced External Counterpulsation']}, {'name': 'Guideline-driven standard medical therapy', 'type': 'DRUG', 'description': 'Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gui-fu Wu, M.D. & Ph.D.', 'role': 'CONTACT', 'email': 'eecpchina@yahoo.com.cn', 'phone': '+86-135-7001-0112'}, {'name': 'Da-ya Yang, M.D.', 'role': 'CONTACT', 'email': 'y2kchocolate@163.com', 'phone': '+86-135-7056-7490'}, {'name': 'Zhi-min Du, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The 1st Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing-feng Wang, M.D.', 'role': 'CONTACT', 'phone': '+86-136-0289-0860'}, {'name': 'Ru-qiong Nie, M.D.', 'role': 'CONTACT', 'phone': '+86-136-0047-9016'}], 'facility': 'The 2nd Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Chen, M.D.', 'role': 'CONTACT', 'phone': '+86-138-0251-8615'}, {'name': 'Xiao-xian Qian, M.D.', 'role': 'CONTACT', 'phone': '+86-137-1926-1500'}], 'facility': 'The 3rd Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Peng, M.D.', 'role': 'CONTACT', 'phone': '+86-136-0036-1608'}], 'facility': 'The 5th Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'Yan Zhang, M.D.', 'role': 'CONTACT', 'email': 'zhangyan1233456@163.com', 'phone': '+86-137-1123-4160'}, {'name': 'Qiang Xie, M.D.', 'role': 'CONTACT', 'email': 'qiangxie2010@sohu.com', 'phone': '+86-138-0273-9667'}], 'overallOfficials': [{'name': 'Zhi-min Du, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 1st Affiliated Hospital of Sun Yat-sen University'}, {'name': 'Gui-fu Wu, M.D. & Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The 1st Affiliated Hospital of Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gui-Fu Wu', 'oldOrganization': 'The First Affiliated Hospital of Sun Yat-Sen University'}}}}