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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01111071
First received: April 16, 2010
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • all-cause 30-day mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    all-cause 30-day mortality following hospitalisation for acute coronary syndrome


Secondary Outcome Measures:
  • all-cause in-hospital mortality [ Time Frame: length of hospital stay ] [ Designated as safety issue: No ]
    all-cause in-hospital mortality following hospitalisation for acute coronary syndrome


Estimated Enrollment: 300000
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111071

Locations
United Kingdom
Epidemiology and Public Health, University College London
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
University College, London
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
  More Information

Additional Information:
Publications:

Responsible Party: Julie George, NIHR Doctoral Fellow, University College, London
ClinicalTrials.gov Identifier: NCT01111071     History of Changes
Other Study ID Numbers: CALIBER-09-03, RP-PG-0407-10314
Study First Received: April 16, 2010
Last Updated: December 19, 2011
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
hospital variation
30 day mortality
in hospital mortality
acute coronary syndrome
myocardial infarction
unstable angina
hospital performance
trends

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014