Myocardial InfarctionPRECLUDE-MINCT03099395
Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI
An observational study of Myocardial Infarction, run by Uppsala University.
Trial summary
Recurrent myocardial infarctions (reinfarctions) can be due to recurrence at the original treatment site, the presence of untreated lesions elsewhere, or in progressive lesions. There are scarce published data describing the localization (affected vessel/s) and severity (NSTE-ACS/STE-ACS) of reinfarction(s) compared… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Oct 2017
- How long will I take part?
- 8 Years
- 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: Patients registered in SWEDHEART with an index-MI within the observation period.
Who may be able to join
- Patients registered in SWEDHEART with an index-MI within the observation period
Who cannot join
- Less than one year follow-up data
- Previous MI
About this study
Official title: Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI - PRECLUDE-MI - A Retrospective Cohort Study
Recurrent myocardial infarctions (reinfarctions) can be due to recurrence at the original treatment site, the presence of untreated lesions elsewhere, or in progressive lesions. There are scarce published data describing the localization (affected vessel/s) and severity (NSTE-ACS/STE-ACS) of reinfarction(s) compared to the index MI (e.g proportion of recurrent infarctions in the previously diseased vessel) in large unselected patient populations. If reinfarctions are generally more severe than index MI/recurrent MI(s), this might have implications for choice of treatment and treatment length.
Moreover, data from unselected patient populations on the overall incidence pattern/rate of patients experiencing multiple reinfarctions is sparse. Patients who experience multiple ischemic events may be a subset of patients who are poor responders to therapy. There is also a possibility that patients with multiple events are less likely to have received evidence-based therapy such as coronary stenting, novel and more effective antithrombotics and modern lipid lowering treatment for the initial event. Poor adherence to secondary prevention measures (e.g. low compliance to medication and adherence to cardiac rehabilitation programs) may also increase the risk of recurrent events.
Read more
Therefore identification of the baseline characteristics, including treatment decision strategies in the setting of a myocardial infarction, among such subjects may allow modifications of the clinical management strategy prior to the occurrence of subsequent ischemic events. Such modifications could include providing a more intensive or additional therapy in certain patient groups or find strategies to improve patient adherence and drug compliance.
A patient with reinfarctions requires more hospitalizations, treatments, laboratory tests, and out-patient visits, resulting in overall increased costs. From the patient perspective, recurrent events result in higher mortality and worsened quality of life.
Read the detailed description
This study will combine the SWEDEHEART registries RIKS-HIA (Registry of Information and Knowledge about Swedish Heart Intensive care Admissions), SCAAR (Swedish Coronary Angiography and Angioplasty Registry) and SEPHIA (the registry for secondary prevention following coronary intensive care); and the Swedish National Population Registry (to obtain data regarding vital status and date of death), Swedish Cause of Death Register (to separate fatal from non-fatal MI), the Swedish Patient Registry (to obtain data on prior medical history) and the Swedish Drug Registry (to obtain prescribed medical treatment and filled prescriptions).
The RIKS-HIA database covers all acute coronary syndrome (ACS) patients treated at heart intensive care units in Sweden and SCAAR entails all PCI procedures performed across all centers in Sweden.
In this study the investigators will include patients with first time ever of NSTE-ACS and STE-ACS and receiving care at cardiac intensive care units and entered in the SWEDEHEART registry between 1 July 2006 and 31 December 2014. Baseline and in-hospital characteristics will be obtained, including peri-procedural anti-thrombotic treatments.
To assess the incidence rate and fatality of reinfarctions in a contemporary unselected MI cohort
To characterize patients with one and multiple reinfarctions during the observation period vs. those without.
To characterize patients with one and multiple reinfarction during the observational period vs. those without.
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No re-MI, one re-MI, > one re-MI | From a population with MI surviving one year (78 468 pts) the number of pts with no re-MI, one re-MI or > re-MI will be described. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of repeat cardiovascular events during follow-up after first diagnosed event-MI.
Measured: max 8 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jun 2015
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Other
- Enrolment
- 100,000 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099395
- Sponsor's protocol ID
- PRECLUDE-MI
- Acronym
- PRECLUDE-MI
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Varenhorst C, Hasvold P, Johansson S, Janzon M, Albertsson P, Leosdottir M, Hambraeus K, James S, Jernberg T, Svennblad B, Lagerqvist B. Culprit and Nonculprit Recurrent Ischemic Events in Patients With Myocardial Infarction: Data From SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies). J Am Heart Assoc. 2018 Jan 9;7(1):e007174. doi: 10.1161/JAHA.117.007174. Epub 2018 Jan 4.
PubMed 31913732
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI - PRECLUDE-MI - A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03099395
- Acronym / sponsor ID
- PRECLUDE-MI / PRECLUDE-MI
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 4 Apr 2017 (actual)
- 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.
Recurrent myocardial infarctions (reinfarctions) can be due to recurrence at the original treatment site, the presence of untreated lesions elsewhere, or in progressive lesions. There are scarce published data describing the localization (affected vessel/s) and severity (NSTE-ACS/STE-ACS) of reinfarction(s) compared to the index MI (e.g proportion of recurrent infarctions in the previously diseased vessel) in large unselected patient populations. If reinfarctions are generally more severe than index MI/recurrent MI(s), this might have implications for choice of treatment and treatment length.
Moreover, data from unselected patient populations on the overall incidence pattern/rate of patients experiencing multiple reinfarctions is sparse. Patients who experience multiple ischemic events may be a subset of patients who are poor responders to therapy. There is also a possibility that patients with multiple events are less likely to have received evidence-based therapy such as coronary stenting, novel and more effective antithrombotics and modern lipid lowering treatment for the initial event. Poor adherence to secondary prevention measures (e.g. low compliance to medication and adherence to cardiac rehabilitation programs) may also increase the risk of recurrent events.
Therefore identification of the baseline characteristics, including treatment decision strategies in the setting of a myocardial infarction, among such subjects may allow modifications of the clinical management strategy prior to the occurrence of subsequent ischemic events. Such modifications could include providing a more intensive or additional therapy in certain patient groups or find strategies to improve patient adherence and drug compliance.
A patient with reinfarctions requires more hospitalizations, treatments, laboratory tests, and out-patient visits, resulting in overall increased costs. From the patient perspective, recurrent events result in higher mortality and worsened quality of life.
Detailed description
This study will combine the SWEDEHEART registries RIKS-HIA (Registry of Information and Knowledge about Swedish Heart Intensive care Admissions), SCAAR (Swedish Coronary Angiography and Angioplasty Registry) and SEPHIA (the registry for secondary prevention following coronary intensive care); and the Swedish National Population Registry (to obtain data regarding vital status and date of death), Swedish Cause of Death Register (to separate fatal from non-fatal MI), the Swedish Patient Registry (to obtain data on prior medical history) and the Swedish Drug Registry (to obtain prescribed medical treatment and filled prescriptions).
The RIKS-HIA database covers all acute coronary syndrome (ACS) patients treated at heart intensive care units in Sweden and SCAAR entails all PCI procedures performed across all centers in Sweden.
In this study the investigators will include patients with first time ever of NSTE-ACS and STE-ACS and receiving care at cardiac intensive care units and entered in the SWEDEHEART registry between 1 July 2006 and 31 December 2014. Baseline and in-hospital characteristics will be obtained, including peri-procedural anti-thrombotic treatments.
To assess the incidence rate and fatality of reinfarctions in a contemporary unselected MI cohort
To characterize patients with one and multiple reinfarctions during the observation period vs. those without.
To characterize patients with one and multiple reinfarction during the observational period vs. those without.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 8 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No re-MI, one re-MI, > one re-MI | – | –From a population with MI surviving one year (78 468 pts) the number of pts with no re-MI, one re-MI or > re-MI will be described. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients registered in SWEDHEART with an index-MI within the observation period.
Key inclusion criteria (1 listed)
- Patients registered in SWEDHEART with an index-MI within the observation period
Key exclusion criteria (2 listed)
- Less than one year follow-up data
- Previous MI
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
Pattern of repeat cardiovascular events during follow-up after first diagnosed event-MI.
Time frame: max 8 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Derived from this study: PubMed 31913732Varenhorst C, Hasvold P, Johansson S, Janzon M, Albertsson P, Leosdottir M, Hambraeus K, James S, Jernberg T, Svennblad B, Lagerqvist B. Culprit and Nonculprit Recurrent Ischemic Events in Patients With Myocardial Infarction: Data From SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies). J Am Heart Assoc. 2018 Jan 9;7(1):e007174. doi: 10.1161/JAHA.117.007174. Epub 2018 Jan 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Uppsala University.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pattern of repeat cardiovascular events during follow-up after first diagnosed event-MI. (time frame: max 8 years follow-up). 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 NCT03099395, 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 5 Apr 2017.