Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT01947361
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2013-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1961286}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-17', 'studyFirstSubmitDate': '2013-09-12', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of atherosclerotic disease in patients with high or low heart rate', 'timeFrame': 'Participants were followed until the first Coronary disease event (an expected average of 5 years)', 'description': 'Hazard ratios will be also presenting associations between heart rate and initial presentation of different cardiovascular diseases. These associations will be also measured between different levels of heart rate and CVDs stratified by:\n\n* by sex\n* gender\n* a range of risk factors (such as physical activity, smoking status, drinking status, etc.)'}], 'secondaryOutcomes': [{'measure': 'Incidence proportions and life time risk for Cardiovascular diseases', 'timeFrame': 'Participants were followed until the first Coronary disease event (an expected average of 5 years)', 'description': 'Subhazard Ratios and Cumulative Incidence estimation of the risk of 12 different cardiovascular diseases adjusted for the 4 different levels of heart rate (\\<60, 60-74, 75-89, \\>90), age and sex in a lifetime period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysm', 'Coronary Heart Disease NOS', 'Unheralded Coronary Death', 'Intracerebral Haemorrhage', 'Heart Failure', 'Ischemic Stroke', 'Myocardial Infarction', 'Stroke', 'Peripheral Arterial Disease', 'Stable Angina Pectoris', 'Subarachnoid Haemorrhage', 'Transient Ischemic Attack', 'Unstable Angina', 'Cardiac Arrest, Sudden Cardiac Death']}, 'referencesModule': {'references': [{'pmid': '29966429', 'type': 'DERIVED', 'citation': 'Archangelidi O, Pujades-Rodriguez M, Timmis A, Jouven X, Denaxas S, Hemingway H. Clinically recorded heart rate and incidence of 12 coronary, cardiac, cerebrovascular and peripheral arterial diseases in 233,970 men and women: A linked electronic health record study. Eur J Prev Cardiol. 2018 Sep;25(14):1485-1495. doi: 10.1177/2047487318785228. Epub 2018 Jul 2.'}], 'seeAlsoLinks': [{'url': 'http://www.caliberresearch.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases.', 'detailedDescription': 'This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).\n* \\> 30 years old\n* have at least a recorded heart rate measurement during the study period\n\nExclusion Criteria:\n\n\\- Evidence of prior atherosclerotic or cardiac disease'}, 'identificationModule': {'nctId': 'NCT01947361', 'briefTitle': 'Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records', 'orgStudyIdInfo': {'id': '12_153R_IP10'}, 'secondaryIdInfos': [{'id': 'RP-PG-0407-10314', 'type': 'OTHER_GRANT', 'domain': 'Wellcome Trust'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1E 7H', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Harry Hemingway', 'investigatorAffiliation': 'University College, London'}}}}