Acute Coronary SyndromeHELICONNCT01984307
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
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 100,000 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with acute coronary syndrome with a history of MI 1-3 years ago.
Who may be able to join
- Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, Myocardial infarction, retrospective, cohort study, Healthcare resources utilization
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of study population in terms of death, cardiovascular disease events and health care resource utilization
- Death (all cause and CVD death) 2. CVD event (MI or Stroke) 3. Health care resource use and costs.
Measured: Follow up period 1-7 years
Assessment of the burden of illness among high risk patients with a history of MI
- 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
Measured: Follow up period 1-7 years
Assessment of the mortality rates among high risk patients with a history of MI
- 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
Measured: 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.
- 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
Measured: Follow up period 1-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magnus Janzon, MD, PhD, Principal investigator, Department of Cardiology, Linköping University Hospital, S-581 85 Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984307
- Sponsor's protocol ID
- ME-CV-1302
- Acronym
- HELICON
- Status last verified
- May 2014
- First submitted
- 22 Oct 2013
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29474723
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01984307
- Acronym / sponsor ID
- HELICON / ME-CV-1302
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, Myocardial infarction, retrospective, cohort study, Healthcare resources utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with acute coronary syndrome with a history of MI 1-3 years ago.
Key inclusion criteria (1 listed)
- Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of study population in terms of death, cardiovascular disease events and health care resource utilization
Time frame: 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 burden of illness among high risk patients with a history of MI
Time frame: 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
Assessment of the mortality rates among high risk patients with a history of MI
Time frame: 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
1 secondary outcome
Description of the high risk patient population in terms of CVD events, bleedings and co-morbidities.
Time frame: Follow up period 1-7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Derived from this study: PubMed 29474723Janzon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Janzon, MD, PhD principal investigator
Department of Cardiology, Linköping University Hospital, S-581 85 Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of study population in terms of death, cardiovascular disease events and health care resource utilization (time frame: Follow up period 1-7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01984307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.