Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-28 @ 5:51 PM
Study NCT ID:
NCT01422057
Status:
UNKNOWN
Last Update Posted:
2014-02-06
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Prediction in Type II Diabetics With Ischemic Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054970', 'term': 'Pure Autonomic Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major cardiovascular event', 'timeFrame': '2 years', 'description': 'Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '2 years'}, {'measure': 'sudden cardiac death', 'timeFrame': '2 years'}, {'measure': 'Total mortality', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'coronary artery disease', 'ischemic heart disease', 'autonomic function', 'heart rate turbulence', 'deceleration capacity', 'severe autonomic failure'], 'conditions': ['Type-2 Diabetes Mellitus', 'Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease', 'detailedDescription': 'In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected.\n\nIn the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity.\n\nThe correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type-2 diabetes\n* coronary artery disease\n\nExclusion Criteria:\n\n* age \\>80 years\n* acute coronary syndrome\n* life expectancy \\<1 year\n* unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01422057', 'briefTitle': 'Risk Prediction in Type II Diabetics With Ischemic Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Thebiosignals.com'}, 'officialTitle': 'Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function', 'orgStudyIdInfo': {'id': '402/2009BO2-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christine Zürn, MD', 'role': 'CONTACT', 'email': 'christine.zuern@med.uni-tuebingen.de', 'phone': '+49 7071 29 83153'}, {'name': 'Axel Bauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Cardiology', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Christine Zürn, MD', 'role': 'CONTACT', 'email': 'christine.zuern@med.uni-tuebingen.de', 'phone': '+49 7071 29 83153'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thebiosignals.com', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Axel Bauer', 'investigatorFullName': 'Axel Bauer', 'investigatorAffiliation': 'Thebiosignals.com'}}}}