Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-29 @ 9:45 PM
Study NCT ID:
NCT01692795
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2012-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Medication Use Before First Myocardial Infarction
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infarct size', 'timeFrame': 'Measured at baseline', 'description': 'Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.'}], 'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'Up to seven years', 'description': 'All cause mortality, using Office for National Statistics (ONS) mortality statistics'}, {'measure': 'Re-infarction', 'timeFrame': 'One year after initial myocardial infarction', 'description': 'Reinfarction will be measured based on data from the General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Myocardial Ischaemia National Audit Project (MINAP) and Office for National Statistics (ONS) mortality data.'}], 'secondaryOutcomes': [{'measure': 'Myocardial infarciton (MI) type', 'timeFrame': 'Measured at baseline', 'description': 'Diagnosed ST-elevation MI or non ST-elevation myocardial infarction'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Antiplatelets', 'Lipid lowering agents', 'ACE inhibitors', 'Angiotensin Receptor Blockers', 'Beta blockers', 'Blood pressure lowering drugs'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Large randomised trials have shown that cardiovascular medications prescribed to patients at high cardiovascular risk are effective in reducing the incidence of cardiovascular events. Their use is recommended in the United Kingdom and international guidelines (e.g. the National Institute of Clinical Excellence). However, these medications do not prevent cardiovascular events in all patients and there is now a body of research investigating the effects of cardiovascular medications on outcomes in myocardial infarction (MI), including clinical presentation, infarct size and post-MI mortality. However, the independent effects of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations to many of the published studies in terms of their cardiovascular drug exposure data. This project utilizes prospectively collected data on cardiovascular drug use, and links to MI data from hospital and mortality records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is comprised of patients with a first myocardial infarction who are registered at those General Practice Research Database (GPRD) practices that agreed to the linkage with the MINAP database, and whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of all United Kingdom (UK) practices, and 98% of people in the UK are registered with a General Practitioner (GP). Therefore the GPRD should be a representative sample of the UK population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients in GPRD practices which are deemed "up to standard" by GPRD criteria will be included if their practice agreed to be linked to the Myocardial Ischaemic National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office for National Statistics (ONS) datasets.\n\nPatients must have at least one year of GPRD "up to standard" registration before the date of first myocardial infarction.\n\nAge over 18. First myocardial infarction occurring between 1st January 2003 and 31st December 2008, as recorded in the HES data or MINAP.\n\nExclusion Criteria:\n\nPatients will be excluded if they do not fulfil one of the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT01692795', 'briefTitle': 'Cardiovascular Medication Use Before First Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'Cardiovascular Medication Prescriptions Before First Myocardial Infarction in Patients With and Without Previously Diagnosed Atherosclerotic Disease: an Analysis of Linked Prospectively Collected Electronic Healthcare Records', 'orgStudyIdInfo': {'id': 'CALIBER_EH3'}, 'secondaryIdInfos': [{'id': '086091/Z/08/Z', 'type': 'OTHER_GRANT', 'domain': 'Wellcome Trust'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MI patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1E 7HT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'London School of Hygiene and Tropical Medicine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Emily Herrett, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}, {'name': 'Harry Hemingway, FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University College, London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College, London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Emily Herrett', 'investigatorAffiliation': 'London School of Hygiene and Tropical Medicine'}}}}