Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 9:51 AM
Study NCT ID:
NCT01897350
Status:
COMPLETED
Last Update Posted:
2014-10-21
First Post:
2013-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2013-07-11', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mass of myocardial oedema measured by CMR', 'timeFrame': 'Day 2 following STEMI'}], 'secondaryOutcomes': [{'measure': 'Extra cellular volume', 'timeFrame': 'Day 2 following STEMI'}]}, 'conditionsModule': {'keywords': ['STEMI', 'Myocardial edema', 'Cardiovascular magnetic resonance'], 'conditions': ['ST Segment Elevation Myocardial Infarction', 'Myocardial Oedema']}, 'descriptionModule': {'briefSummary': 'Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint. The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 patients will be undergo a CMR scan day 2 following STEMI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* STEMI\n* providing written informed consent\n\nExclusion Criteria:\n\n* contraindication to CMR,\n* atrial fibrillation,\n* claustrophobia,\n* eGFR \\< 30'}, 'identificationModule': {'nctId': 'NCT01897350', 'briefTitle': 'Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial', 'organization': {'class': 'OTHER', 'fullName': 'University of Bristol'}, 'orgStudyIdInfo': {'id': 'Study 1953'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CMR following ST segment myocardial infarction', 'interventionNames': ['Other: Cardiac magnetic resonance imaging']}], 'interventions': [{'name': 'Cardiac magnetic resonance imaging', 'type': 'OTHER', 'armGroupLabels': ['CMR following ST segment myocardial infarction']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS2 8HW', 'city': 'Bristol', 'state': 'Avon', 'country': 'United Kingdom', 'facility': 'Bristol Heart Institute', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elisa McAlindon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Elisa McAlindon', 'investigatorAffiliation': 'University of Bristol'}}}}