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Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Harry Hemingway, University College, London.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
University College, London
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Harry Hemingway, University College, London
ClinicalTrials.gov Identifier:
NCT01947361
First received: September 12, 2013
Last updated: September 17, 2013
Last verified: September 2013
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | September 12, 2013 | ||
| Last Updated Date | September 17, 2013 | ||
| Start Date ICMJE | January 2012 | ||
| Estimated Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Risk of atherosclerotic disease in patients with high or low heart rate [ Time Frame: Participants were followed until the first Coronary disease event (an expected average of 5 years) ] 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:
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE |
Incidence proportions and life time risk for Cardiovascular diseases [ Time Frame: Participants were followed until the first Coronary disease event (an expected average of 5 years) ] 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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber) | ||
| Official Title ICMJE | Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records | ||
| Brief Summary | Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases. | ||
| Detailed Description | 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). | ||
| Study Type ICMJE | Observational | ||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Non-Probability Sample | ||
| Study Population | 1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices | ||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Unknown status | ||
| Enrollment ICMJE | 1961286 | ||
| Estimated Completion Date | December 2014 | ||
| Estimated Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Evidence of prior atherosclerotic or cardiac disease |
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| Sex/Gender |
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| Ages | 30 Years and older (Adult, Senior) | ||
| Accepts Healthy Volunteers | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United Kingdom | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01947361 | ||
| Other Study ID Numbers ICMJE | 12_153R_IP10 RP-PG-0407-10314 ( Other Grant/Funding Number: Wellcome Trust ) |
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| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | Not Provided | ||
| Responsible Party | Harry Hemingway, University College, London | ||
| Study Sponsor ICMJE | University College, London | ||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||
| PRS Account | University College, London | ||
| Verification Date | September 2013 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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