Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-03 @ 10:19 PM
Study NCT ID:
NCT01580566
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Acute MI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples to measure bio-markers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-18', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in renal function and structure', 'timeFrame': 'Baseline, discharge, 1 month, 6 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'renal response to myocardial infarction', 'timeFrame': 'baseline, discharge, 1 month, 6 months and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction (MI)', 'Kidney function', 'bio-markers'], 'conditions': ['Myocardial Infarction', 'Kidney Function']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a sizable myocardial infarction (heart attack) results in negative changes to renal structure and function (i.e. has a negative impact on the kidneys).\n\nTo determine if the renal response to a myocardial infarction is a predictor of the patients future health.', 'detailedDescription': 'Chronic heart and kidney disease are increasingly common in Western society. Both conditions are associated with frequent hospitalisation and increased mortality. Furthermore, there are mechanistic reasons why one condition may beget the other; the so-called "cardiorenal syndrome". The investigators therefore wish to determine if a sizable myocardial infarction (heart attack) results in negative changes to renal structure and function (i.e. has a negative impact on the kidneys). The investigators also wish to determine if the renal response to a myocardial infarction is a predictor of the patients future health. To do this the investigators will measure markers of kidney function at the time of the heart attach, at discharge, 1 month, 6 months and 12 months and correlate this with the patients clinical condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have presented to the Emergency Department with chest pain caused by a possible myocardial infarction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\> 18 years\n\nHave provided written informed consent\n\nGroup 1:\n\n* Non-Q wave MI patients\n* normal cardiac and renal function\n* No use of contrast\n* eGFR \\> 60ml/min\n\nGroup 2:\n\n* Patients undergoing coronary angiography +/- PCI for stable CAD or non-Q wave MI\n* normal cardiac and renal function\n* eGFR \\> 60ml/min\n\nGroup 3:\n\n* Acute STEMI Full thickness infarct (STEMI)\n* eGFR ≥ 60ml/min\n\nGroup 4:\n\n* Acute STEMI Full thickness infarct (STEMI)\n* eGFR \\< 60ml/min\n\nExclusion Criteria:\n\n* Unable or unwilling to comply with the study protocol\n* Underlying medical condition which, in the opinion of the investigator, will effect the safely or efficacy of the study'}, 'identificationModule': {'nctId': 'NCT01580566', 'briefTitle': 'Renal Acute MI Study', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Renal Structural, Functional and Cytokine Responses to Acute Myocardial Injury in Man', 'orgStudyIdInfo': {'id': 'CP-03/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 - Control', 'description': 'Non-Q wave MI subjects with normal cardiac and renal function (defined as eGFR \\>60ml/min) not undergoing a cardiac procedure involving contrast will serve as "control" for renal injury subjects.'}, {'label': 'Group 2 - stable CAD or non-Q wave MI', 'description': 'Patients undergoing coronary angiography +/- PCI for stable CAD or non-Q wave MI with normal cardiac and renal function (defined as eGFR \\>60ml/min) will control for the contrast STEMI patients are likely to receive as part of their post-MI management'}, {'label': 'Group 3 - Acute STEMI without chronic kidney disease', 'description': 'Acute STEMI patients (n=40), without chronic kidney disease (defined as eGFR ≥60ml/min).'}, {'label': 'Group 4 - Acute STEMI with kidney disease', 'description': 'Acute STEMI patients (n=40), with evidence of background chronic kidney disease (eGFR \\<60ml/min).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Henry Krum, MBBS FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred Hospital/Monash.University'}, {'name': 'Henry Krum, MBBS FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred Hospital/Monash University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Seniour Lecturer', 'investigatorFullName': 'Ingrid Hopper', 'investigatorAffiliation': 'Monash University'}}}}