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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Linköping, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.

Exclusion criteria

Not applicable

Treatment and study plan

Primary outcomes

Description of study population in terms of death, cardiovascular disease events and health care resource utilization

Time frame: Follow up period 1-7 years
- Death (all cause and CVD death) 2. CVD event (MI or Stroke) 3. Health care resource use and costs.
Assessment of the burden of illness among high risk patients with a history of MI

Time frame: Follow up period 1-7 years
- 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
Assessment of the mortality rates among high risk patients with a history of MI

Time frame: Follow up period 1-7 years
- 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 outcomes

Description of the high risk patient population in terms of CVD events, bleedings and co-morbidities.

Time frame: Follow up period 1-7 years
- 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: HELICON

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Nov 14, 2013
Registry last updated: May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed