ST-elevation Myocardial InfarctionNCT02600962
Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction
An observational study of ST-elevation Myocardial Infarction and Non ST-elevation Myocardial Infarction, run by University of Leeds.
Trial summary
The aim of the study is to investigate the impact of an initial non-specific / non-cardiac diagnosis on mortality among patients hospitalised with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- ST-elevation Myocardial Infarction, Non ST-elevation Myocardial Infarction
- How many people
- 564,412 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Apr 2013
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises 725,860 patients hospitalised for acute myocardial infarction and entered into the Myocardial Ischaemia National Audit Project (MINAP) database between April 2004 and March 2013.
Who may be able to join
- patients aged between 18 and 100 years
- patients discharged alive with STEMI or NSTEMI
Who cannot join
- patients who die in hospital
- patients not discharged with STEMI or NSTEMI
About this study
Official title: Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction: A National Cohort Study
The aim of the study is to investigate the impact of an initial non-specific / non-cardiac diagnosis on mortality among patients hospitalised with acute myocardial infarction.
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
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 |
|---|---|---|
| STEMI | Patients discharged with STEMI | |
| NSTEMI | Patients discharged with NSTEMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Mortality censored 1 year after discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startJan 2003
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 564,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Dr Christopher Gale, University of Leeds
- Investigators
- Christopher P Gale, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600962
- Sponsor's protocol ID
- Initial diagnosis study
- Other IDs
- PG/13/81/30474
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2015
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction: A National Cohort Study
- ClinicalTrials.gov ID
- NCT02600962
- Acronym / sponsor ID
- Initial diagnosis study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564,412 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Jan 2003
- Primary completion
- Apr 2013 (actual)
- First posted
- 9 Nov 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 investigate the impact of an initial non-specific / non-cardiac diagnosis on mortality among patients hospitalised with acute myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | –Patients discharged with STEMI |
| NSTEMI | – | –Patients discharged with NSTEMI |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises 725,860 patients hospitalised for acute myocardial infarction and entered into the Myocardial Ischaemia National Audit Project (MINAP) database between April 2004 and March 2013.
Key inclusion criteria (2 listed)
- patients aged between 18 and 100 years
- patients discharged alive with STEMI or NSTEMI
Key exclusion criteria (2 listed)
- patients who die in hospital
- patients not discharged with STEMI or NSTEMI
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: Mortality censored 1 year after discharged from hospital
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 9 Nov 2015.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of ST-elevation Myocardial Infarction and Non ST-elevation 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 2 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 9 Nov 2015. 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: Mortality censored 1 year after discharged from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2015.