Myocardial InfarctionREBUSNCT01102933
RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients
An observational study of Myocardial Infarction, run by Uppsala University at 1 site in Sweden.
Trial summary
The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to: Evaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- How many people
- 425 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2010to Aug 2012
- 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: All patients diagnosed wilth myocardial infarction and hospitalized at the Cardiology Department, Uppsala University Hospital, the study population will be unselected.
Who may be able to join
- Myocardial infarction diagnosed by dynamic raised troponin I with at least one value above 0.1 µg/L. Together with at least one of the criteria; symptoms suggestive for myocardial infarction or development of significant Q wave.
- Treated at the Department of cardiology, Uppsala University Hospital.
- Ability to attend the scheduled visits for evaluation procedures.
- Signed Informed Consent.
Who cannot join
- Death ≤ 5 days after the myocardial infarction.
- Not belonging to the catchment area of Uppsala University Hospital.
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Cardiology Department
Uppsal University Hospital, Uppsala County, 751 85
About this study
Official title: RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)
The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to:
Evaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population with a recent myocardial infarction.
Evaluate if an early change of biomarkers can be related to death, new myocardial infarction, and ischemic stroke in the same population after two and five years follow-up.
- Conditions
- 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 |
|---|---|---|
| Unselected post-myocard infarct patients | Patients diagnosed with MI at Uppsala University Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, myocardial infarction, stroke
Death: Death will be sub-classified by vascular or non-vascular primary cause. All deaths with unknown/uncertain cause will be categorized as vascular death.
Myocardial Infarction(MI): Rehospitalization due to new non fatal MI or development of significant Q-wave.
Stroke: Diagnosed as abrupt onset of focal neurological deficit persisting more than 24 hours.
Measured: Five years from study start
Secondary outcomes (1)
Venous thromboembolism, Arterial embolism, Bleeding
Venous thromboembolism: Deep venous thrombosis has to be diagnosed by ultrasonography or venography. Pulmonary embolism has to be diagnosed by spiral CT scan, pulmonary angiogram or ventilation-perfusion scanning.
Arterial embolism: Diagnosed as an arterial event. Radiological evidence includes imaging studies.
Bleedings: Classified as major or minor using International Society on Thrombosis and Haemostasis (ISTH). Major bleeds will be diagnosed as fatal and/or symptomatic bleeding in critical area or organ and/or bleeding associated with a decrease in Hb of 20 g/L or more or leading to transfusion.
Measured: Five years from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Christersson, MD PhD, Principal investigator, Cardiology Department, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102933
- Sponsor's protocol ID
- U-09-003
- Acronym
- REBUS
- Status last verified
- Mar 2014
- First submitted
- 12 Apr 2010
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)
- ClinicalTrials.gov ID
- NCT01102933
- Acronym / sponsor ID
- REBUS / U-09-003
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Apr 2010 (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.
The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to:
Evaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population with a recent myocardial infarction.
Evaluate if an early change of biomarkers can be related to death, new myocardial infarction, and ischemic stroke in the same population after two and five years follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unselected post-myocard infarct patients | – | –Patients diagnosed with MI at Uppsala University Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed wilth myocardial infarction and hospitalized at the Cardiology Department, Uppsala University Hospital, the study population will be unselected.
Key inclusion criteria (4 listed)
- Myocardial infarction diagnosed by dynamic raised troponin I with at least one value above 0.1 µg/L. Together with at least one of the criteria; symptoms suggestive for myocardial infarction or development of significant Q wave.
- Treated at the Department of cardiology, Uppsala University Hospital.
- Ability to attend the scheduled visits for evaluation procedures.
- Signed Informed Consent.
Key exclusion criteria (3 listed)
- Death ≤ 5 days after the myocardial infarction.
- Not belonging to the catchment area of Uppsala University Hospital.
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
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
Death, myocardial infarction, stroke
Time frame: Five years from study start
Death: Death will be sub-classified by vascular or non-vascular primary cause. All deaths with unknown/uncertain cause will be categorized as vascular death. Myocardial Infarction(MI): Rehospitalization due to new non fatal MI or development of significant Q-wave. Stroke: Diagnosed as abrupt onset of focal neurological deficit persisting more than 24 hours.
1 secondary outcome
Venous thromboembolism, Arterial embolism, Bleeding
Time frame: Five years from study start
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 26 Mar 2014.
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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.
Christina Christersson, MD PhD principal investigator
Cardiology Department, Uppsala University Hospital
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 Myocardial Infarction, run by Uppsala University 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 4 inclusion and 3 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 26 Mar 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?
Death, myocardial infarction, stroke (time frame: Five years from study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2014.