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

Acute Coronary Syndrome Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984307
• Other study ID #: ME-CV-1302
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: May 12, 2014
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The Swedish National Board of Health and Welfare"
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100000
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.

Exclusion Criteria:

• Not applicable

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Sweden	Research Site	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of study population in terms of death, cardiovascular disease events and health care resource utilization	1. Death (all cause and CVD death) 2. CVD event (MI or Stroke) 3. Health care resource use and costs.	Follow up period 1-7 years	No
Primary	Assessment of the burden of illness among high risk patients with a history of MI	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	Follow up period 1-7 years	No
Primary	Assessment of the mortality rates among high risk patients with a history of MI	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	Follow up period 1-7 years	No
Secondary	Description of the high risk patient population in terms of CVD events, bleedings and co-morbidities.	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	Follow up period 1-7 years	No