Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-29 @ 12:45 PM
Study NCT ID:
NCT01122069
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2010-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast Echocardiography in Non-ST Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042852', 'term': 'perflutren'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2010-05-10', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-ST-Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '25692527', 'type': 'DERIVED', 'citation': 'Eskerud I, Gerdts E, Nordrehaug JE, Lonnebakken MT. Global Coronary Artery Plaque Area is Associated with Myocardial Hypoperfusion in Women with Non-ST Elevation Myocardial Infarction. J Womens Health (Larchmt). 2015 May;24(5):367-73. doi: 10.1089/jwh.2014.4920. Epub 2015 Feb 18.'}, {'pmid': '22752464', 'type': 'DERIVED', 'citation': 'Lonnebakken MT, Nordrehaug JE, Gerdts E. No gender difference in the extent of myocardial ischemia in non-ST elevation myocardial infarction. Eur J Prev Cardiol. 2014 Jan;21(1):123-9. doi: 10.1177/2047487312454107. Epub 2012 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'In patients with acute myocardial infarction, treatment logistics are primarily defined based upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without ST elevation (NSTEMI) are initially medically treated and recommended coronary angiography within 48-72 hours.\n\nEarly invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction (TIMI) risk score to identify patients who will benefit from early intervention due to high risk of new infraction and cardiovascular death. However, new research has suggested that TIMI risk score may not always identify patients with severe angiographic disease.\n\nThe purpose of this study was to assess if contrast echocardiography could be used to identify NSTEMI patients with angiographically severe disease independent of their TIMI risk score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '110 patients with acute non-ST elevation myocardial infarction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute non-ST elevation myocardial infarction\n\nExclusion Criteria:\n\n* hemodynamic unstable\n* mechanical prosthetic heart valve\n* severly reduced pulmonary function'}, 'identificationModule': {'nctId': 'NCT01122069', 'briefTitle': 'Contrast Echocardiography in Non-ST Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Contrast Echocardiography in Assessment of Myocardial Perfusion in Patients With Non-ST Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'MCE-NSTEMI'}, 'secondaryIdInfos': [{'id': 'REK237.07', 'type': 'OTHER', 'domain': 'Regional Ethics Committee West Norway'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Contrast echocardiography', 'description': '110 patients with acute non-ST elevation myocardial infarct were examined with contrast echocardiography prior to coronary angiography.', 'interventionNames': ['Other: Perflutren Lipid Microsphere ultrasound contrast']}], 'interventions': [{'name': 'Perflutren Lipid Microsphere ultrasound contrast', 'type': 'OTHER', 'otherNames': ['Luminity'], 'description': 'Perflutren Lipid Microsphere ultrasound contrast 0.01 ml/kg administered as intravenous bolus', 'armGroupLabels': ['Contrast echocardiography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Department of Heart Disease, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Mai Tone Lønnebakken, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen, Bergen, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Eva Gerdts', 'investigatorAffiliation': 'University of Bergen'}}}}