- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02952417
Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction
November 1, 2016 updated by: Oras Alabas, University of Leeds
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
180000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Excess mortality rate ratio
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
November 1, 2016
First Posted (Estimate)
November 2, 2016
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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