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Acute Myocardial InfarctionNCT01359033

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

An observational study of Acute Myocardial Infarction, run by University College, London at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 30 years and older
Conditions the study is for
Acute Myocardial Infarction
How many people
510,863 participants
Where
2 sitesin 2 countries
Study dates
Mar 2011to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Sweden1 site

  • Uppsala Clinial Research Center

    Uppsala, SE-751 85

Other trials in Sweden

United Kingdom1 site

  • University College London

    London

Other trials in United Kingdom

About this study

Official title: Compare the Patient Risk and Between-hospital Variation in Myocardial Infarction Mortality in the United Kingdom and Sweden

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

Read the 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.

Keywords
Myocardial Infarction, UK, Sweden, National audit registry, MINAP, RIKS-HIA
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01359033
Study groupRoleWhat they receive
MINAP cohortThe 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 cohortThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality

    all-cause mortality at 30-day following hospitalization for acute Myocardial Infarction

    Measured: 30-day

Secondary outcomes (1)

  1. 1-year mortality

    all-cause mortality at 1-year following hospitalization for acute Myocardial Infarction

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
510,863 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01359033
Sponsor's protocol ID
FP7-EIS-WP7-MINAP
Status last verified
Feb 2014
First submitted
23 May 2011
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Rosvall M, Ohlsson H, Hansen O, Chaix B, Merlo J. Auditing patient registration in the Swedish quality register for acute coronary syndrome. Scand J Public Health. 2010 Jul;38(5):533-40. doi: 10.1177/1403494810365109. Epub 2010 Apr 20.

    PubMed 20406796

  • Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L. The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart. 2010 Oct;96(20):1617-21. doi: 10.1136/hrt.2010.198804. Epub 2010 Aug 27.

    PubMed 20801780

  • Birkhead JS, Walker L, Pearson M, Weston C, Cunningham AD, Rickards AF; National Audit of Myocardial Infarction Project Steering Group. Improving care for patients with acute coronary syndromes: initial results from the National Audit of Myocardial Infarction Project (MINAP). Heart. 2004 Sep;90(9):1004-9. doi: 10.1136/hrt.2004.034470.

    PubMed 15310686

  • Birkhead JS, Weston C, Lowe D. Impact of specialty of admitting physician and type of hospital on care and outcome for myocardial infarction in England and Wales during 2004-5: observational study. BMJ. 2006 Jun 3;332(7553):1306-11. doi: 10.1136/bmj.38849.440914.AE. Epub 2006 May 16.

    PubMed 16705004

  • Chung SC, Sundstrom J, Gale CP, James S, Deanfield J, Wallentin L, Timmis A, Jernberg T, Hemingway H; Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies/Register of Information and Knowledge about Swedish Heart Intensive care Admissions; National Institute for Cardiovascular Outcomes Research/Myocardial Ischaemia National Audit Project; CAardiovascular Disease Research Using Linked Bespoke Studies and Electronic Health Records. Comparison of hospital variation in acute myocardial infarction care and outcome between Sweden and United Kingdom: population based cohort study using nationwide clinical registries. BMJ. 2015 Aug 7;351:h3913. doi: 10.1136/bmj.h3913.

    PubMed 26254445

  • Chung SC, Gedeborg R, Nicholas O, James S, Jeppsson A, Wolfe C, Heuschmann P, Wallentin L, Deanfield J, Timmis A, Jernberg T, Hemingway H. Acute myocardial infarction: a comparison of short-term survival in national outcome registries in Sweden and the UK. Lancet. 2014 Apr 12;383(9925):1305-1312. doi: 10.1016/S0140-6736(13)62070-X. Epub 2014 Jan 23.

    PubMed 24461715

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, run by University College, London at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day mortality (time frame: 30-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01359033, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

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