Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 7:16 AM
Study NCT ID:
NCT00845468
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Flow Reserve and Glucometabolic State
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary flow reserve', 'diabetes mellitus', 'acute myocardial infarction', 'transthoracic echocardiography'], 'conditions': ['Acute Myocardial Infarction', 'Diabetes Mellitus', 'Prediabetes']}, 'referencesModule': {'references': [{'pmid': '19833304', 'type': 'DERIVED', 'citation': 'Logstrup BB, Hofsten DE, Christophersen TB, Moller JE, Botker HE, Pellikka PA, Egstrup K. Influence of abnormal glucose metabolism on coronary microvascular function after a recent myocardial infarction. JACC Cardiovasc Imaging. 2009 Oct;2(10):1159-66. doi: 10.1016/j.jcmg.2009.06.012.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus is a major risk factor for the development of ischemic heart disease, and patients with diabetes mellitus have a worse outcome following an acute myocardial infarction than non-diabetic patients. Furthermore, abnormal glucose metabolism below the diagnostic threshold of diabetes mellitus is also associated with increased risk of death compared to patients with a normal glucose metabolism. The frequency of abnormal glucose metabolism in acute myocardial infarction is high, and approximately 70% of myocardial infarction patients have diabetes mellitus, newly diagnosed diabetes mellitus or impaired glucose tolerance, leaving only 30% with normal glucose metabolism. The increased mortality among patients with acute myocardial infarction and abnormal glucose metabolism seems mainly related to a higher occurrence of congestive heart failure, suggesting that an abnormal glucose metabolism may play an important role among others in endothelial dysfunction, infarct healing and overall left ventricle function. This raises the question, whether patients with acute myocardial infarction and abnormal glucose metabolism have increased frequency of micro- or macrovascular disease or both.\n\nCoronary flow velocity reserve reflects the patency of the epicardial coronary artery in combination with vasodilator capacity of the microcirculation and may therefore offer a tool for assessment of macro- and microcirculation.\n\nThis study will focus on the relation between coronary flow velocity reserve estimated by transthoracal Doppler echocardiography and mortality, risk for heart failure and left ventricle function after acute myocardial infarction stratified according to glycometabolic state'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from a acute myocardial infarction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed first AMI based on characteristic clinical symptoms and/or electrocardiographic signs of AMI and Troponin T or I or CK-MB over diagnostic limits for AMI\n2. Referral for coronary arteriography based on the actual myocardial infarction\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Previous myocardial infarction\n2. Asthma bronchiale\n3. 2 or/and 3 degree atrio-ventricular block and paced rhythm\n4. Mental state that makes the patient unavailable in attending the study\n5. Use of dipyridamol\n6. Sick Sinus Syndrome'}, 'identificationModule': {'nctId': 'NCT00845468', 'briefTitle': 'Coronary Flow Reserve and Glucometabolic State', 'organization': {'class': 'OTHER', 'fullName': 'Medicinsk Forsknings Afdeling'}, 'officialTitle': 'Coronary Flow Velocity Reserve According to Glucometabolic State in Acute Myocardial Infarction; Relation to Ventricular Systolic and Diastolic Function', 'orgStudyIdInfo': {'id': '07-4-B368-A1392-22379'}, 'secondaryIdInfos': [{'id': 'VF 20050103'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5700', 'city': 'Svendborg', 'state': 'Svendborg', 'country': 'Denmark', 'facility': 'Hospital of Fünen Svendborg', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}], 'overallOfficials': [{'name': 'Brian B Løgstrup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicinsk Forsknings Afdeling'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicinsk Forsknings Afdeling', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Brian Bridal Løgstrup', 'oldOrganization': 'Medicinsk Forskning Afdeling'}}}}