Non ST-elevation Myocardial InfarctionNCT02436187
Guideline Recommended Care and Excess Mortality for Non ST-elevation Myocardial Infarction : A National Cohort Study
An observational study of Non ST-elevation Myocardial Infarction, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of the study is to quantify the excess mortality associated with non-adherence to care for non ST-elevation myocardial infarction in England and Wales over the last decade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST-elevation Myocardial Infarction
- How many people
- 389,057 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2003to Jun 2013
- How long will I take part?
- 10 Years
- 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: The study population comprised of 389,052 patients with non ST-elevation myocardial infarction admitted to hospital and were entered into Myocardial Ischaemia National Audit Project database between January 2003 and December 2013.
Who may be able to join
- aged 18 years or more
- patients hospitalised with non ST-elevation myocardial infarction
Who cannot join
- patients hospitalised with phenotypes other than non ST-elevation myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to quantify the excess mortality associated with non-adherence to care for non ST-elevation myocardial infarction in England and Wales over the last decade.
- Conditions
- Non ST-elevation Myocardial Infarction
- Keywords
- NSTEMI, excess mortality, evidence-based care, MINAP
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Participants will be followed up for an expected average of 8 years 6 months
Secondary outcomes (1)
Number of missed guideline recommended care opportunities
Measured: Participants will be followed up for an expected average of 8 years 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJan 2003
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non ST-elevation 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
- 389,057 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatendashe Bernadette Dondo, University of Leeds
- Investigators
- Christopher P Gale, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436187
- Sponsor's protocol ID
- PG/13/81/30474
- Status last verified
- Jun 2019
- First submitted
- 30 Mar 2015
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dondo TB, Hall M, Timmis AD, Gilthorpe MS, Alabas OA, Batin PD, Deanfield JE, Hemingway H, Gale CP. Excess mortality and guideline-indicated care following non-ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2017 Aug;6(5):412-420. doi: 10.1177/2048872616647705. Epub 2016 May 3.
PubMed 27142174Dondo TB, Hall M, Timmis AD, Yan AT, Batin PD, Oliver G, Alabas OA, Norman P, Deanfield JE, Bloor K, Hemingway H, Gale CP. Geographic variation in the treatment of non-ST-segment myocardial infarction in the English National Health Service: a cohort study. BMJ Open. 2016 Jul 12;6(7):e011600. doi: 10.1136/bmjopen-2016-011600.
PubMed 27406646
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline Recommended Care and Excess Mortality for Non ST-elevation Myocardial Infarction : A National Cohort Study
- ClinicalTrials.gov ID
- NCT02436187
- Acronym / sponsor ID
- PG/13/81/30474
- Conditions
- Non ST-elevation Myocardial Infarction
- Keywords
- NSTEMI, excess mortality, evidence-based care, MINAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389,057 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 May 2015 (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.
The aim of the study is to quantify the excess mortality associated with non-adherence to care for non ST-elevation myocardial infarction in England and Wales over the last decade.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised of 389,052 patients with non ST-elevation myocardial infarction admitted to hospital and were entered into Myocardial Ischaemia National Audit Project database between January 2003 and December 2013.
Key inclusion criteria (2 listed)
- aged 18 years or more
- patients hospitalised with non ST-elevation myocardial infarction
Key exclusion criteria (1 listed)
- patients hospitalised with phenotypes other than non ST-elevation myocardial infarction
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: Participants will be followed up for an expected average of 8 years 6 months
1 secondary outcome
Number of missed guideline recommended care opportunities
Time frame: Participants will be followed up for an expected average of 8 years 6 months
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 18 Jun 2019.
- Background: PubMed 27142174Dondo TB, Hall M, Timmis AD, Gilthorpe MS, Alabas OA, Batin PD, Deanfield JE, Hemingway H, Gale CP. Excess mortality and guideline-indicated care following non-ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2017 Aug;6(5):412-420. doi: 10.1177/2048872616647705. Epub 2016 May 3.
- Background: PubMed 27406646Dondo TB, Hall M, Timmis AD, Yan AT, Batin PD, Oliver G, Alabas OA, Norman P, Deanfield JE, Bloor K, Hemingway H, Gale CP. Geographic variation in the treatment of non-ST-segment myocardial infarction in the English National Health Service: a cohort study. BMJ Open. 2016 Jul 12;6(7):e011600. doi: 10.1136/bmjopen-2016-011600.
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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.
Christopher P Gale, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non ST-elevation Myocardial Infarction, run by University of Leeds at 1 site in United Kingdom.
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 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Mortality (time frame: Participants will be followed up for an expected average of 8 years 6 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 NCT02436187, which also lists 2 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 18 Jun 2019.