Myocardial Infarction Clinical Trial
— OPTAMIOfficial title:
OPTAMI (Optimierte Therapie Des Akuten Myokard-Infarktes) - Register
Verified date | September 2010 |
Source | Stiftung Institut fuer Herzinfarktforschung |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
OPTAMI documents the characteristics of consecutive patients with acute STEMI and NSTEMI in
hospital everyday-life in Germany, their acute and adjuvant medication treatment, events
until discharge (e.g. mortality, stroke, re-MI), and their medication for secondary
prevention at discharge.
In the follow up-period of one year, information is collected concerning events as
mortality, stroke, re-MI, coronary interventions (PCI, CABG) and re-hospitalisation.
The implementation of guideline-adjusted therapy in hospital everyday-life is reviewed. The
usefulness of the European standard for data acquisition in cardiology (CARDS = Cardiology
Audit and Registration Standards) is evaluated.
Status | Completed |
Enrollment | 3248 |
Est. completion date | February 2010 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - all patients admitted to hospital with an acute ST-Elevation myocardial infarction or with an acute Non-ST-Elevation myocardial infarction, both not older than 24 h Exclusion Criteria: - missing informed consent |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Klinik und Poliklinik, Universitätklinikum Münster | Münster | |
Germany | Klinikum Nürnberg Süd / Cardiology | Nürnberg |
Lead Sponsor | Collaborator |
---|---|
Stiftung Institut fuer Herzinfarktforschung | GlaxoSmithKline, Klinikum Nürnberg, University Hospital Muenster |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Documentation of characteristics from consecutive patients with an acute STEMI or an acute NSTEMI in hospital daily routine in Germany. | 10/01/2005-02/01/2009 | No | |
Secondary | Documentation of acute invasive and adjuvant medical therapy of STEMI and NSTEMI in hospital daily routine in Germany | 10/01/2005-02/01/2009 | No | |
Secondary | Documentation of hospital mortality and non-fatal cerebrovascular complications (stroke, re-myocardial infarction) | 10/01/2005-02/01/2009 | No | |
Secondary | Documentation of medication for secondary prevention at hospital discharge | 10/01/2005-02/01/2009 | No | |
Secondary | Documentation of the one-year mortality, the non-fatal cerebrovascular complications (stroke, re-myocardial infarction) as well as of the coronar interventions (PCI, Bypass operation) and hospital admissions during the first year post STEMI or NSTEMI | 10/01/2005-02/01/2009 | No | |
Secondary | Verification of the benefits of the European Standards for Data Collection for Cardiology (CARDS = Cardiology Audit and Register Standards) in daily hospital routine. | 10/01/2005-02/01/2009 | No | |
Secondary | Verification of the implementation of therapy according to the guidelines for STEMI and NSTEMI patients in daily hospital routine in Germany. | 10/01/2005-02/01/2009 | No |
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