Acute Myocardial InfarctionNCT01819103
Investigating Variation in Hospital Acute Coronary Syndrome Outcomes
An observational study of Acute Myocardial Infarction, run by University of Leeds.
Trial summary
To investigate the causes of hospital variation in outcomes from acute coronary syndromes in England and develop recommendations for improving patient care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 5,555 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2013
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 5555 consented patients were recruited from acute Trusts in England.
Who may be able to join
- Age > 18 years, both sexes, acute admission to the acute Trust with suspected acute coronary syndrome (ACS).
Who cannot join
- Patients at a terminal stage of any illness, and those in whom follow up would be inappropriate or impractical.
About this study
Official title: Evaluation of the Methods and Management of Acute Coronary Events-4: 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.
Read the 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 depend 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, patient experience of hospital care and whether patients take their medication after discharge from hospital.
Notably, the challenges posed by poor drug adherence to secondary prevention medications are recognised by the World Health Organisation as the highest area of priority for improving individual health throughout the world. In addition, Patient Reported Outcome Measures (PROMs) are set to be the cornerstone of the evaluation of patient experiences of National Health Service quality of care.
Using 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.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Mortality, Acute Myocardial Infarction, Drug Adherence, Drug Compliance, Health-related quality of life
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute myocardial infarction | Drug Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 12 months
Secondary outcomes (1)
Drug Adherence
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 5,555 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oras Alabas, University of Leeds
- Investigators
- Chris P Gale, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819103
- Sponsor's protocol ID
- 12/WM/0431
- Status last verified
- Apr 2013
- First submitted
- 23 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Munyombwe T, Dondo TB, Hall M, Nadarajah R, Hurdus B, Aktaa S, Haris M, Keeley A, West R, Hall A, Norman P, Gale CP. Cohort profile: Evaluation of the Methods and Management of Acute Coronary Events (EMMACE) Longitudinal Cohort. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):442-446. doi: 10.1093/ehjqcco/qcad040.
PubMed 37451698Dondo 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.
PubMed 36351712Munyombwe 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.
PubMed 34579718Munyombwe 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.
PubMed 31699696
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Methods and Management of Acute Coronary Events-4: Investigating Variation in Hospital Acute Coronary Syndrome Outcomes
- ClinicalTrials.gov ID
- NCT01819103
- Acronym / sponsor ID
- 12/WM/0431
- Conditions
- Acute Myocardial Infarction
- Keywords
- Mortality, Acute Myocardial Infarction, Drug Adherence, Drug Compliance, Health-related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,555 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the causes of hospital variation in outcomes from acute coronary syndromes in England and develop recommendations for improving patient care.
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 depend 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, patient experience of hospital care and whether patients take their medication after discharge from hospital.
Notably, the challenges posed by poor drug adherence to secondary prevention medications are recognised by the World Health Organisation as the highest area of priority for improving individual health throughout the world. In addition, Patient Reported Outcome Measures (PROMs) are set to be the cornerstone of the evaluation of patient experiences of National Health Service quality of care.
Using 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarction | – | –Drug Adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 5555 consented patients were recruited from acute Trusts in England.
Key inclusion criteria (1 listed)
- Age > 18 years, both sexes, acute admission to the acute Trust with suspected acute coronary syndrome (ACS).
Key exclusion criteria (1 listed)
- Patients at a terminal stage of any illness, and those in whom follow up would be inappropriate or impractical.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 12 months
1 secondary outcome
Drug Adherence
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Derived from this study: PubMed 37451698Munyombwe T, Dondo TB, Hall M, Nadarajah R, Hurdus B, Aktaa S, Haris M, Keeley A, West R, Hall A, Norman P, Gale CP. Cohort profile: Evaluation of the Methods and Management of Acute Coronary Events (EMMACE) Longitudinal Cohort. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):442-446. doi: 10.1093/ehjqcco/qcad040.
- Derived from this study: PubMed 36351712Dondo 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.
- Derived from this study: PubMed 34579718Munyombwe 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.
- Derived from this study: PubMed 31699696Munyombwe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris P Gale, PhD principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by University of Leeds.
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 1 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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: 12 months). 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 NCT01819103, which also lists 4 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 4 Apr 2013.