Acute Myocardial InfarctionNCT02952417
Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by University of Leeds.
Trial summary
The aim of this study was to estimate the impact of sex on relative survival and excess mortality following acute myocardial infarction (AMI) using a population-based cohort within a relative survival framework. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Excess mortality
- How many people
- 180,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Jan 2014
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013
Who may be able to join
- Patients were included if they are aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013
Who cannot join
- -
About this study
Official title: Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction: National Cohort Study Using the SWEDEHEART Registry
The aim of this study was to estimate the impact of sex on relative survival and excess mortality following acute myocardial infarction (AMI) using a population-based cohort within a relative survival framework. Patient-level data concerning demographics, co-morbidity, cardiovascular risk factors and treatments at discharge were extracted from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for patients hospitalized with acute coronary syndrome. Patients were followed-up for their vital status after AMI hospitalisation, with censoring at the end of follow-up on the 31st of December, 2013.
Read the detailed description
Details of SWEDEHEART and data validation have been described previously. Cases of acute myocardial infarction were defined as STEMI and NSTEMI according to the current European Society of Cardiology, American College of Cardiology and American Heart Association guidelines and determined at local level by the attending Consultant.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Excess mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excess mortalityOther
Relative survival was defined as the observed survival among patients with STEMI and NSTEMI divided by the expected survival in the age, sex and year matched populace of Sweden.
| Study group | Role | What they receive |
|---|---|---|
| STEMI and NSTEMI Women | Women with ST-segment elevation myocardial infarction (STEMI) and women non-STEMI (NSTEMI) who survived following acute myocardial infarction and at risk of excess mortality. Receives: Other: Excess mortality | |
| STEMI and NSTEMI Men | Men with ST-segment elevation myocardial infarction (STEMI) and women non-STEMI (NSTEMI) who survived following acute myocardial infarction and at risk of excess mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess mortality rate ratio
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startDec 2003
- Primary completionDec 2013
- Study completionJan 2014
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
- 180,000 participants (actual)
- Target duration
- 10 Years
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
- NCT02952417
- Sponsor's protocol ID
- 1.001
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Alabas OA, Gale CP, Hall M, Rutherford MJ, Szummer K, Lawesson SS, Alfredsson J, Lindahl B, Jernberg T. Sex Differences in Treatments, Relative Survival, and Excess Mortality Following Acute Myocardial Infarction: National Cohort Study Using the SWEDEHEART Registry. J Am Heart Assoc. 2017 Dec 14;6(12):e007123. doi: 10.1161/JAHA.117.007123.
PubMed 29242184
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction: National Cohort Study Using the SWEDEHEART Registry
- ClinicalTrials.gov ID
- NCT02952417
- Acronym / sponsor ID
- 1.001
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180,000 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Nov 2016 (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 this study was to estimate the impact of sex on relative survival and excess mortality following acute myocardial infarction (AMI) using a population-based cohort within a relative survival framework. Patient-level data concerning demographics, co-morbidity, cardiovascular risk factors and treatments at discharge were extracted from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for patients hospitalized with acute coronary syndrome. Patients were followed-up for their vital status after AMI hospitalisation, with censoring at the end of follow-up on the 31st of December, 2013.
Detailed description
Details of SWEDEHEART and data validation have been described previously. Cases of acute myocardial infarction were defined as STEMI and NSTEMI according to the current European Society of Cardiology, American College of Cardiology and American Heart Association guidelines and determined at local level by the attending Consultant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI and NSTEMI Women | – | Other: Excess mortalityWomen with ST-segment elevation myocardial infarction (STEMI) and women non-STEMI (NSTEMI) who survived following acute myocardial infarction and at risk of excess mortality. |
| STEMI and NSTEMI Men | – | –Men with ST-segment elevation myocardial infarction (STEMI) and women non-STEMI (NSTEMI) who survived following acute myocardial infarction and at risk of excess mortality. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013
Key inclusion criteria (1 listed)
- Patients were included if they are aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excess mortalityRelative survival was defined as the observed survival among patients with STEMI and NSTEMI divided by the expected survival in the age, sex and year matched populace of Sweden. | Other | STEMI and NSTEMI Women |
Primary outcome
Excess mortality rate ratio
Time frame: 10 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 2 Nov 2016.
- Derived from this study: PubMed 29242184Alabas OA, Gale CP, Hall M, Rutherford MJ, Szummer K, Lawesson SS, Alfredsson J, Lindahl B, Jernberg T. Sex Differences in Treatments, Relative Survival, and Excess Mortality Following Acute Myocardial Infarction: National Cohort Study Using the SWEDEHEART Registry. J Am Heart Assoc. 2017 Dec 14;6(12):e007123. doi: 10.1161/JAHA.117.007123.
- 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.
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 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 2 Nov 2016. 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?
Excess mortality rate ratio (time frame: 10 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 NCT02952417, 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 2 Nov 2016.