Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT00338156
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2006-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of the Remodelling Process Following Myocardial Infarct
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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_WITHOUT_DNA', 'description': 'Serum Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2006-06-16', 'studyFirstSubmitQcDate': '2006-06-16', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Left Ventricle Remodelling', 'Collagen markers', 'Neurohormones', 'Cardiac MRI'], 'conditions': ['Heart Failure', 'Myocardial Infarct']}, 'descriptionModule': {'briefSummary': 'This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.', 'detailedDescription': 'A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years.\n\nThe present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction.\n\nThe data collected at the 3-year follow-up visit will be compared to data from the initial study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with risk of heart failure secondary to myocardial infarct.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in the previous neurohormonal substudy of the OPTIMAAL trial\n* Willingness to participate in the present study and ability to understand and sign the written informed consent\n\nExclusion Criteria:\n\n* Myocardial infarction within 3 months of visit 1.\n* Significant primary valve disease, confirmed by ECHO cardiography,\n* Autoimmune disease likely to cause an increase in collagen turnover\n* Active cancer disease\n* Immunosuppressive treatment,\n* Significantly reduced liver function\n* Contraindications for performing a cardiac MRI scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to Omniscan™).\n* Inability to cooperate during the 1 month follow up period.'}, 'identificationModule': {'nctId': 'NCT00338156', 'briefTitle': 'Observational Study of the Remodelling Process Following Myocardial Infarct', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Stavanger HF'}, 'officialTitle': 'Assessment of the Relationship Between Collagen Turnover, Left Ventricular Remodelling and Myocardial Scarring Assessed by Cardiac Magnetic Resonance and Neurohumoral Activation in Patients With Previous Myocardial Infarction', 'orgStudyIdInfo': {'id': 'StaHF461302'}, 'secondaryIdInfos': [{'id': 'Helse Vest 911017', 'type': 'OTHER_GRANT', 'domain': 'Helse Vest RHF'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-4011', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'overallOfficials': [{'name': 'Kenneth Dickstein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helse Stavanger HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Helse Vest', 'class': 'OTHER'}, {'name': 'Amersham Buchler, GmbH & Co KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}