A Retrospective Swedish Cohort Study on Health Outcomes, Life Expectancy, Resource Use and Costs in Patients With a History of Myocardial Infarction and Additional Risk Factors for Atherothrombosis

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01984307
• Lead Sponsor: AstraZeneca

Brief Summary

To characterize and estimate the size of different populations with a history of acute coronary syndrome in Sweden. To assess the burden of illness (co-morbidities, mortality rates healthcare resource utilization and atherothrombotic events) among patients with a history of myocardial infarction (MI) 1-3 years ago and additional risk factors for atherothrombosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-22
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-14
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

• Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the burden of illness among high risk patients with a history of MI	Follow up period 1-7 years	1. Describe patients' demographics and clinical characteristics 2. Assess rate of CV event (MI and stroke), CV mortality and all cause mortality 3. Assess rate of CV events (MI and stroke), CV mortality and all cause mortality in patients having at least 24 months and 36 months without MI, respectively 4. Assess the impact of additional atherothrombotic risk factors 5. Describe treatment patterns 6. Evaluate healthcare resource use and costs 7. Assess predictors of new CV events (MI and stroke), CV mortality and all cause mortality
Description of study population in terms of death, cardiovascular disease events and health care resource utilization	Follow up period 1-7 years	1. Death (all cause and CVD death) 2. CVD event (MI or Stroke) 3. Health care resource use and costs.
Assessment of the mortality rates among high risk patients with a history of MI	Follow up period 1-7 years	1. Describe patients' demographics and clinical characteristics 2. Assess rate of CV event (MI and stroke), CV mortality and all cause mortality 3. Assess rate of CV events (MI and stroke), CV mortality and all cause mortality in patients having at least 24 months and 36 months without MI, respectively 4. Assess the impact of additional atherothrombotic risk factors 5. Describe treatment patterns 6. Evaluate healthcare resource use and costs 7. Assess predictors of new CV events (MI and stroke), CV mortality and all cause mortality

Secondary Outcome Measures

Name	Time	Method
Description of the high risk patient population in terms of CVD events, bleedings and co-morbidities.	Follow up period 1-7 years	1. Assess rate of other CVD events (including heart failure, atrial fibrillation, angina pectoris) 2. Assess prevalence and rate of (major) organ specific bleedings (recorded diagnose in hospital) 3. Describe patients/proportions of patients with increased bleeding risk (history of previous bleedings, age, anti-thrombotic treatment etc) 4. Assess the prevalence of major co-morbidities in this population: (e.g. bradycardia, insertion of pacemaker, acute liver and renal failure) 5. To describe the death rate for the most common cause of deaths in the study population relative to the standardized death rate in the Swedish population and calculate the standardised mortality ratio

Trial Locations

Locations (1)

Research Site; 🇸🇪 Linkoping, Sweden