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

May 11, 2016 updated by: Julie George, University College, London
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

316648

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 6BT
        • Epidemiology and Public Health, University College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause 30-day mortality
Time Frame: 30 day
all-cause 30-day mortality following hospitalisation for acute coronary syndrome
30 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause in-hospital mortality
Time Frame: length of hospital stay
all-cause in-hospital mortality following hospitalisation for acute coronary syndrome
length of hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

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

Investigators

  • Principal Investigator: Julie L George, MSc, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALIBER-09-03
  • RP-PG-0407-10314 (Other Grant/Funding Number: Wellcome Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

permissions to use anonymised data from data owners do not allow further sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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