MI Mortality Risk and Between-hospital Risk Variation in the United Kingdom and Sweden

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NICOR/MINAP, the United Kingdom
NICOR: National Institute for Cardiac Outcomes Research
MINAP: Myocardial Ischaemia National Audit Project
SWEDEHEART/RIKS-HIA, Sweden
SWEDEHEART: Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies
RIKS-HIA: Register of Information and Knowledge about Swedish Heart Intensive care Admissions
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01359033
First received: May 23, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The study aims to investigate the differences in survival trajectories and hospital variability in myocardial infarction (MI) mortality rates in the UK and Sweden.


Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Compare the Patient Risk and Between-hospital Variation in Myocardial Infarction Mortality in the United Kingdom and Sweden

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 30-day mortality [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    all-cause mortality at 30-day following hospitalization for acute Myocardial Infarction


Secondary Outcome Measures:
  • 1-year mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    all-cause mortality at 1-year following hospitalization for acute Myocardial Infarction


Estimated Enrollment: 370000
Study Start Date: March 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
MINAP cohort
The Myocardial Ischaemia National Audit Project (MINAP) was established in 1999, in response to the national service framework (NSF) for coronary heart disease, to examine the quality of management of heart attacks (myocardial infarction) in hospitals in England and Wales.
RIKS-HIA cohort
The Register of Information and Knowledge About Swedish Heart Intensive Care Admissions (RIKS-HIA) has been established to record clinical and treatment information for all patients admitted to the coronary care units in Sweden from 1995.

Detailed Description:

Limited evidence is available in comparing hospital level care and reference mortality risks between countries, due to the scarce availability of nationwide coronary heart disease data. The demographics and medical expenditure percentage are comparable in the United Kingdom and Sweden; however, the in-hospital case-fatality rates within 30 days after admission for acute myocardial infarction was greater in the UK than Sweden (6.3% versus 2.9%)(OECD, 2009). To investigate the discrepancy, the current study aims to compare the mortality risk differences and associated explanatory factors between the two countries. Results of the study can contribute to myocardial infarction care implementation in the UK and Sweden.

The UK Myocardial Ischaemia National Audit Project (MINAP)and Register of Information and Knowledge about Swedish Heart Intensive care Admissions (RIKS-HIA) are few quality national registries currently available for acute coronary syndrome. Using data from the MINAP and RIKS-HIA, we propose to investigate (1)the survival trajectories for a reference patient with myocardial infarction and (2) hospital variability in myocardial infarction mortality rate in the UK and Sweden, adjusted for important patient-level and hospital-level covariates.

  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

For the UK, all patients with an admission recorded in the MINAP database during 1st January 2004 and 31 December 2008 in 253 hospitals in England and Wales will be included in the study. For Sweden, all patients with an admission recorded in the RIKS-HIA during 1st January 2004 and 31 December 2008 in 74 hospitals in Sweden will be included. Only patients with acute myocardial infarction will be included as the study population.

Criteria

Inclusion Criteria:

  • Patients aged above 30 years old who had hospital admission for acute myocardial infarction.
  • Admission period ranged from 1st January, 2004 to 31th December, 2008.

Exclusion Criteria:

  • Patients with missing data in the admission time and/or primary outcomes.
  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: NCT01359033

Locations
Sweden
Uppsala Clinial Research Center
Uppsala, Sweden, SE-751 85
United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
University College, London
NICOR/MINAP, the United Kingdom
NICOR: National Institute for Cardiac Outcomes Research
MINAP: Myocardial Ischaemia National Audit Project
SWEDEHEART/RIKS-HIA, Sweden
SWEDEHEART: Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies
RIKS-HIA: Register of Information and Knowledge about Swedish Heart Intensive care Admissions
Investigators
Principal Investigator: Sheng-Chia Chung, Ph.D University College, London
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01359033     History of Changes
Other Study ID Numbers: FP7-EIS-WP7-MINAP
Study First Received: May 23, 2011
Last Updated: February 3, 2014
Health Authority: United Kingdom: the Myocardial Ischaemia National Audit Project Academic Group

Keywords provided by University College, London:
Myocardial Infarction
UK
Sweden
National audit registry
MINAP
RIKS-HIA

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014