Acute Myocardial InfarctionNCT03749694
Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction.
An observational study of Acute Myocardial Infarction, run by University of Leeds.
Trial summary
The aim of the study was to use data from the Myocardial Ischaemia National Audit Project (MINAP) to investigate whether temporal improvements in survival were associated with changes in patients' baseline clinical risk or use of guideline-indicated treatments for the management of STEMI, and to determine the extent… 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
- 232,353 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 30 Jun 2013
- How long will I take part?
- 7 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 232,353 in hospital survivors of ST-elevation myocardial infarction recorded in the Myocardial Ischaemia National Audit Project registry between 2004 and June 2013.
Who may be able to join
- aged 18 years or more
- patients hospitalised with ST-elevation myocardial infarction
Who cannot join
- patients hospitalised with phenotypes other than ST-elevation myocardial infarction
About this study
Official title: Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction: A Causal Mediation Analysis Using the Myocardial Ischaemia National Audit Project, 2004-2013.
The aim of the study was to use data from the Myocardial Ischaemia National Audit Project (MINAP) to investigate whether temporal improvements in survival were associated with changes in patients' baseline clinical risk or use of guideline-indicated treatments for the management of STEMI, and to determine the extent to which associations explained the temporal improvements in survival.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, mortality, evidence-based care, Myocardial Ischaemia National Audit Project, ST-elevation myocardial infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: one year
Secondary outcomes (1)
All cause mortality
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jan 2004
- Primary completion30 Jun 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 232,353 participants (actual)
- Target duration
- 7 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
- Chris P Gale, FRCP, Principal investigator, University of LeedsTatendashe B Dondo, PhD, Principal investigator, University of LeedsMarlous Hall, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749694
- Sponsor's protocol ID
- PG/13/81/30474_STEMI
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dondo TB, Hall M, Munyombwe T, Wilkinson C, Yadegarfar ME, Timmis A, Batin PD, Jernberg T, Fox KA, Gale CP. A nationwide causal mediation analysis of survival following ST-elevation myocardial infarction. Heart. 2020 May;106(10):765-771. doi: 10.1136/heartjnl-2019-315760. Epub 2019 Nov 15.
PubMed 31732655
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction: A Causal Mediation Analysis Using the Myocardial Ischaemia National Audit Project, 2004-2013.
- ClinicalTrials.gov ID
- NCT03749694
- Acronym / sponsor ID
- PG/13/81/30474_STEMI
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, mortality, evidence-based care, Myocardial Ischaemia National Audit Project, ST-elevation myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232,353 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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 was to use data from the Myocardial Ischaemia National Audit Project (MINAP) to investigate whether temporal improvements in survival were associated with changes in patients' baseline clinical risk or use of guideline-indicated treatments for the management of STEMI, and to determine the extent to which associations explained the temporal improvements in survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 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 232,353 in hospital survivors of ST-elevation myocardial infarction recorded in the Myocardial Ischaemia National Audit Project registry between 2004 and June 2013.
Key inclusion criteria (2 listed)
- aged 18 years or more
- patients hospitalised with ST-elevation myocardial infarction
Key exclusion criteria (1 listed)
- patients hospitalised with phenotypes other than 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
All cause mortality
Time frame: one year
1 secondary outcome
All cause mortality
Time frame: six 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 21 Nov 2018.
- Derived from this study: PubMed 31732655Dondo TB, Hall M, Munyombwe T, Wilkinson C, Yadegarfar ME, Timmis A, Batin PD, Jernberg T, Fox KA, Gale CP. A nationwide causal mediation analysis of survival following ST-elevation myocardial infarction. Heart. 2020 May;106(10):765-771. doi: 10.1136/heartjnl-2019-315760. Epub 2019 Nov 15.
- Individual participant dataSharing planned: No
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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, FRCP principal investigator
University of Leeds
Tatendashe B Dondo, PhD principal investigator
University of Leeds
Marlous Hall, 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 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 21 Nov 2018. 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?
All cause mortality (time frame: one year). 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 NCT03749694, which also lists 1 linked publication.
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 21 Nov 2018.