Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01164371
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2010-07-15
Brief Title:
Gender Differences in the Development Treatment and Prognosis of Coronary Disease A CALIBER Study
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina Myocardial Infarction or Unheralded Coronary Death A CALIBER Study Using Linked GPRD-MINAP Data
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The initial manifestation of symptomatic coronary disease can range from angina or symptoms of angina unheralded acute coronary syndrome ACS or unheralded coronary death A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease could help to identify which gender- specific factors might reduce or slow transition to more serious disease states and improve outcomes The investigators research focuses on the role primary care management of cardiovascular risk factors plays in gender differences in the progression to subsequent disease states and to mortality
Detailed Description:
The initial manifestation of symptomatic coronary disease can range from angina or symptoms of angina unheralded acute coronary syndrome or unheralded coronary death Gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease are not well understood Furthermore while the management of coronary risk factors in primary care is hypothesized to play a key role in the rate and timing of such transitions little is known about the impact such management has on gender differences these transitions and outcomes
Study Objectives
1 To determine gender differences in probabilities of transitions from symptom-free state to mortality for each of three patient coronary disease pathways where the initial disease manifestation is angina myocardial infarction or unheralded coronary death
2 To determine the role management of coronary risk factors in primary care has in explaining any gender differences in transitions from symptom-free state to mortality for each of the three patient coronary disease pathways
A statistical analytic protocol for the first part of this study comparing patients with unheralded coronary death to patients free of symptomatic coronary disease dated June 2010 is available on request A second statistical analytic protocol for the second part of this study comparing initial presentation of coronary disease within a framework of competing risks of atherosclerotic disease dated December 2011 is available on request
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 09H081016 and ECC approval ref ECC 2-06b2009 CALIBER dataset
Study Objectives
1 To determine gender differences in probabilities of transitions from symptom-free state to mortality for each of three patient coronary disease pathways where the initial disease manifestation is angina myocardial infarction or unheralded coronary death
2 To determine the role management of coronary risk factors in primary care has in explaining any gender differences in transitions from symptom-free state to mortality for each of the three patient coronary disease pathways
A statistical analytic protocol for the first part of this study comparing patients with unheralded coronary death to patients free of symptomatic coronary disease dated June 2010 is available on request A second statistical analytic protocol for the second part of this study comparing initial presentation of coronary disease within a framework of competing risks of atherosclerotic disease dated December 2011 is available on request
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 09H081016 and ECC approval ref ECC 2-06b2009 CALIBER dataset
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None