NCT02952417

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

10 years

First QC Date

October 31, 2016

Last Update Submit

November 1, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Excess mortality rate ratio

    10 years

Study Arms (2)

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.

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.

Interventions

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 Women

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Mortality

Intervention Hierarchy (Ancestors)

Vital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

December 1, 2003

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share