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Completed

NCT Number: NCT01111071

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Epidemiology and Public Health, University College London

London, WC1E 6BT, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. all-cause 30-day mortality

    Time frame: 30 day

    all-cause 30-day mortality following hospitalisation for acute coronary syndrome

Secondary outcomes

  1. all-cause in-hospital mortality

    Time frame: length of hospital stay

    all-cause in-hospital mortality following hospitalisation for acute coronary syndrome

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Barts & The London NHS Trust
  • Queen Mary University of London
  • University of Bristol
  • Yale University

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 27, 2010
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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