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 (HELICON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01984307
First received: October 22, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Description of study population in terms of death, cardiovascular disease events and health care resource utilization [ Time Frame: Follow up period 1-7 years ] [ Designated as safety issue: No ]
    1. 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 ] [ Designated as safety issue: No ]
    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

  • Assessment of the mortality rates among high risk patients with a history of MI [ Time Frame: Follow up period 1-7 years ] [ Designated as safety issue: No ]
    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:
  • Description of the high risk patient population in terms of CVD events, bleedings and co-morbidities. [ Time Frame: Follow up period 1-7 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100000
Study Start Date: August 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient with acute coronary syndrome with a history of MI 1-3 years ago.

Criteria

Inclusion Criteria:

- Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.

Exclusion Criteria:

- Not applicable

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984307

Locations
Sweden
Research Site
Linkoping, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Magnus Janzon, MD, PhD Department of Cardiology, Linköping University Hospital, S-581 85 Linköping, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01984307     History of Changes
Other Study ID Numbers: ME-CV-1302
Study First Received: October 22, 2013
Last Updated: May 12, 2014
Health Authority: Sweden: The Swedish National Board of Health and Welfare"

Keywords provided by AstraZeneca:
Acute coronary syndrome
Myocardial infarction
retrospective
cohort study
Healthcare resources utilization

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014