RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients

NCT01102933 | Completed

• 1 other identifier: U-09-003
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Five years from study start

Secondary Outcomes (1)

• Venous thromboembolism, Arterial embolism, Bleeding

  Five years from study start

Study Arms (1)

Unselected post-myocard infarct patients

Patients diagnosed with MI at Uppsala University Hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed wilth myocardial infarction and hospitalized at the Cardiology Department, Uppsala University Hospital, the study population will be unselected.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Cardiology Department

Uppsal University Hospital, Uppsala County, 751 85, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for analysis of biomarkers and platelets. At the first visit after the hospital stay blood for DNA analysis will also be collected.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Christina Christersson, MD PhD

  Cardiology Department, Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

SE (1)