- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01808027
Investigating Variation in Hospital Acute Coronary Syndrome Outcomes
March 7, 2013 updated by: Oras Alabas, University of Leeds
Evaluation of the Methods and Management of Acute Coronary Events: 3. Investigating Variation in Hospital Acute Coronary Syndrome Outcomes
To investigate the causes of hospital variation in outcomes from acute coronary syndromes in England and develop recommendations for improving patient care.
Study Overview
Status
Completed
Conditions
Detailed Description
Over the last few years the chance of dying from a heart attack in England and Wales has reduced dramatically.
Even so, there remain huge differences in mortality between hospitals.
For example, up to a third of patients with a heart attack who attend hospitals in England are more likely to die than would be expected.
That is, the type of treatment and the risk of death depends upon where a patient lives and which hospital they attend.
In part, the variation in death may be due to the services available at the hospital or to factors such as socioeconomic deprivation.
It may also relate to other factors such as depression, cardiac rehabilitation and whether patients take their medication after discharge from hospital.
Using powerful statistical approaches that include measures of quality of life, we propose to examine data about heart attacks in England and investigate the 'postcode lottery of care'.
Our aim, using regional data about heart attacks is to identify and measure the effects of hospital care.
This research will identify hospital qualities that promote improved patient care.
In doing so, best practice will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.
Study Type
Observational
Enrollment (Actual)
5555
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
-
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West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS2 9JT
- University of Leeds
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consented patients with acute coronary syndrome were recruited from acute Trusts in England.
These hospitals have been selected because of their diverse population demographics, different acute coronary syndrome care pathways and established track record for good data collection.
Specifically these hospitals represent both teaching hospitals and community hospitals - but more importantly include a wide range of patient types.
Mortality tracked through the UK statistics authority, and primary and secondary endpoints tracked locally and transferred through the secure NHS net to a central database.
Description
Inclusion Criteria:
- Age > 18 years
- Both sexes
- Acute admission to the acute Trust with suspected acute coronary syndrome
Exclusion Criteria:
- Patients at a terminal stage of any illness
- Those in whom follow up would be inappropriate or impractical
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Acute myocardial infarction
patient with suspected acute coronary syndrome (ACS).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
delays to treatment
Time Frame: 12 months
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Quantification of hospital attributable effects relating to early and late mortality
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describing trajectories of quality of life recovery patterns
Time Frame: 12 month
|
Describing trajectories of quality of life recovery patterns
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12 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Develop a risk score and a near-point risk Acute Coronary Syndrome model
Time Frame: two years
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Develop a risk score and a near-point risk Acute Coronary Syndrome model
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two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chris P Gale, PhD, University of Leeds
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
- Dondo TB, Munyombwe T, Hall M, Hurdus B, Soloveva A, Oliver G, Aktaa S, West RM, Hall AS, Gale CP. Sex differences in health-related quality of life trajectories following myocardial infarction: national longitudinal cohort study. BMJ Open. 2022 Nov 8;12(11):e062508. doi: 10.1136/bmjopen-2022-062508.
- Munyombwe T, Dondo TB, Aktaa S, Wilkinson C, Hall M, Hurdus B, Oliver G, West RM, Hall AS, Gale CP. Association of multimorbidity and changes in health-related quality of life following myocardial infarction: a UK multicentre longitudinal patient-reported outcomes study. BMC Med. 2021 Sep 28;19(1):227. doi: 10.1186/s12916-021-02098-y.
- Hurdus B, Munyombwe T, Dondo TB, Aktaa S, Oliver G, Hall M, Doherty P, Hall AS, Gale CP. Association of cardiac rehabilitation and health-related quality of life following acute myocardial infarction. Heart. 2020 Nov;106(22):1726-1731. doi: 10.1136/heartjnl-2020-316920. Epub 2020 Aug 21.
- Munyombwe T, Hall M, Dondo TB, Alabas OA, Gerard O, West RM, Pujades-Rodriguez M, Hall A, Gale CP. Quality of life trajectories in survivors of acute myocardial infarction: a national longitudinal study. Heart. 2020 Jan;106(1):33-39. doi: 10.1136/heartjnl-2019-315510. Epub 2019 Nov 7.
- Alabas OA, West RM, Gillott RG, Khatib R, Hall AS, Gale CP; EMMACE-3 Investigators. Evaluation of the Methods and Management of Acute Coronary Events (EMMACE)-3: protocol for a longitudinal study. BMJ Open. 2015 Jun 23;5(6):e006256. doi: 10.1136/bmjopen-2014-006256.
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
February 1, 2011
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
March 7, 2013
First Submitted That Met QC Criteria
March 7, 2013
First Posted (Estimate)
March 8, 2013
Study Record Updates
Last Update Posted (Estimate)
March 8, 2013
Last Update Submitted That Met QC Criteria
March 7, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/H1313/74
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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