NCT01984307

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

October 22, 2013

Last Update Submit

May 12, 2014

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndromeMyocardial infarctionretrospectivecohort studyHealthcare resources utilization

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (1)

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

    Follow up period 1-7 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \- Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.

You may not qualify if:

  • \- Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Linköping, Sweden

Location

Related Publications (1)

  • Janzon M, Henriksson M, Hasvold P, Hjelm H, Thuresson M, Jernberg T. Long-term resource use patterns and healthcare costs after myocardial infarction in a clinical practice setting: results from a contemporary nationwide registry study. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):291-298. doi: 10.1093/ehjqcco/qcw019.

    PMID: 29474723DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Magnus Janzon, MD, PhD

    Department of Cardiology, Linköping University Hospital, S-581 85 Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

November 14, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

SE(1)