Effect of Diabetes on Long Term Excess Mortality Following Acute Myocardial InfarctionNCT02591576
Long Term Excess Mortality of Acute Myocardial Infarction in Patients With and Without Diabetes: A Population-based Cohort Study
An observational study of Effect of Diabetes on Long Term Excess Mortality Following Acute Myocardial Infarction, run by University of Leeds.
Trial summary
Diabetes is key risk factor for death following acute myocardial infarction. However, the long-term excess risk of death associated with diabetes following acute myocardial infarction not known. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Effect of Diabetes on Long Term Excess Mortality Following Acute Myocardial Infarction
- How many people
- 700,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jul 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: STEMI and NSTEMI were eligible for analysis if they have been hospitalised following AMI between the period of 2003-2013 and were aged at least 18 years. Only records of the first admission were considered for analyses.
Who may be able to join
- Acute myocardial infarction
- Both sex
- 18 years
Who cannot join
None listed.
About this study
Diabetes is key risk factor for death following acute myocardial infarction. However, the long-term excess risk of death associated with diabetes following acute myocardial infarction not known. Investigators aimed to determine the long-term excess risk of death associated with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.
- Keywords
- Diabetes, ST-elevation myocardial infarction (STEMI), non-STEMI, Excess mortality, Relative survival
- Medical subject headings
- Diabetes Mellitus, 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 |
|---|---|---|
| ST-elevation myocardial infarction (STEMI) | Not described | |
| non-ST-elevation myocardial infarction (NSTEMI) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term excess mortality
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJan 2003
- Primary completionJul 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 Effect of Diabetes on Long Term Excess Mortality Following 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
- Retrospective
- Enrolment
- 700,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oras Alabas, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591576
- Sponsor's protocol ID
- NIGB: ECC 1-06 (d)/2011
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alabas OA, Hall M, Dondo TB, Rutherford MJ, Timmis AD, Batin PD, Deanfield JE, Hemingway H, Gale CP. Long-term excess mortality associated with diabetes following acute myocardial infarction: a population-based cohort study. J Epidemiol Community Health. 2017 Jan;71(1):25-32. doi: 10.1136/jech-2016-207402. Epub 2016 Jun 15.
PubMed 27307468
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Excess Mortality of Acute Myocardial Infarction in Patients With and Without Diabetes: A Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT02591576
- Acronym / sponsor ID
- NIGB: ECC 1-06 (d)/2011
- Keywords
- Diabetes, ST-elevation myocardial infarction (STEMI), non-STEMI, Excess mortality, Relative survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700,000 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jul 2013 (actual)
- First posted
- 29 Oct 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.
Diabetes is key risk factor for death following acute myocardial infarction. However, the long-term excess risk of death associated with diabetes following acute myocardial infarction not known. Investigators aimed to determine the long-term excess risk of death associated with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST-elevation myocardial infarction (STEMI) | – | – |
| non-ST-elevation myocardial infarction (NSTEMI) | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI and NSTEMI were eligible for analysis if they have been hospitalised following AMI between the period of 2003-2013 and were aged at least 18 years. Only records of the first admission were considered for analyses.
Key inclusion criteria (3 listed)
- Acute myocardial infarction
- Both sex
- 18 years
Key exclusion criteria (0 listed)
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
Long term excess mortality
Time frame: 8 years
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 29 Oct 2015.
- Derived from this study: PubMed 27307468Alabas OA, Hall M, Dondo TB, Rutherford MJ, Timmis AD, Batin PD, Deanfield JE, Hemingway H, Gale CP. Long-term excess mortality associated with diabetes following acute myocardial infarction: a population-based cohort study. J Epidemiol Community Health. 2017 Jan;71(1):25-32. doi: 10.1136/jech-2016-207402. Epub 2016 Jun 15.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Diabetes on Long Term Excess Mortality Following 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 3 inclusion and 0 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 29 Oct 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?
Long term excess mortality (time frame: 8 years). 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 NCT02591576, 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 29 Oct 2015.