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Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study

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ClinicalTrials.gov Identifier: NCT01111071
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : May 12, 2016
Sponsor:
Collaborators:
Barts & The London NHS Trust
Queen Mary University of London
University of Bristol
Yale University
Information provided by (Responsible Party):
Julie George, University College, London

Tracking Information
First Submitted Date April 16, 2010
First Posted Date April 27, 2010
Last Update Posted Date May 12, 2016
Study Start Date April 2010
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2010)
all-cause 30-day mortality [ Time Frame: 30 day ]
all-cause 30-day mortality following hospitalisation for acute coronary syndrome
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01111071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 23, 2010)
all-cause in-hospital mortality [ Time Frame: length of hospital stay ]
all-cause in-hospital mortality following hospitalisation for acute coronary syndrome
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study
Official Title Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study
Brief Summary We seek to investigate whether hospitals in England and Wales vary in their rate of mortality following admission for heart attack or unstable angina, the extent of such variation, whether discharge diagnosis affects the extent of variation, and whether such variation has changed over time. Furthermore, we will investigate what individual- or hospital-level factors explain variation in mortality between hospitals.
Detailed Description

Several studies have looked at between-hospital variation in mortality following myocardial infarction but have lacked patient-level data. Those with individual-level data have been limited by:

  • use of in-hospital mortality as an outcome measure, which can be affected by length of stay,
  • restriction to patients aged 65 and over, or otherwise selected patients, and
  • patient-level explanatory factors lacking clinical detail, particularly medications given in hospital.

MINAP patient-level data allow the investigation of hospital variation in mortality (in-hospital and 30-day) in a group of unselected patients, taking into account clinical details such as medication use in hospital, as well as features of the hospitals providing care. The proposed study will establish the extent of variation between hospitals in England and Wales, whether this varies by ACS diagnosis, whether the variation has reduced over time and finally which patient-level or hospital-level factors explain any variation found.

A statistical analytic protocol for this study, dated 15.4.2010, 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 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients admitted with acute coronary syndrome to acute hospitals in England and Wales participating in the Myocardial Ischaemia National Audit Project (MINAP)
Condition Acute Coronary Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • STEMI
    patients with discharge diagnosis of ST elevation myocardial infarction
  • nSTEMI
    patients with discharge diagnosis of non ST elevation myocardial infarction
  • unstable angina
    patients with discharge diagnosis of unstable angina
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2016)
316648
Original Estimated Enrollment
 (submitted: April 23, 2010)
300000
Actual Study Completion Date December 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • admitted between January 2003 to June 2009 (or latest date data available)

Exclusion Criteria:

  • admitted to hospital with fewer than 25 admissions in given year
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01111071
Other Study ID Numbers CALIBER-09-03
RP-PG-0407-10314 ( Other Grant/Funding Number: National Institute of Health Research (UK) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: permissions to use anonymised data from data owners do not allow further sharing.
Responsible Party Julie George, University College, London
Study Sponsor University College, London
Collaborators
  • Barts & The London NHS Trust
  • Queen Mary University of London
  • University of Bristol
  • Yale University
Investigators
Principal Investigator: Julie L George, MSc University College, London
PRS Account University College, London
Verification Date May 2016