Clinical trial NCT01197729: OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry
Official title: OPTAMI (Optimierte Therapie Des Akuten Myokard-Infarktes) - Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
ST-Elevation Myocardial Infarction
Non-ST-Elevation Myocardial Infarction
Keywords: Myocardial infarction
ST-Elevation myocardial infarction
Non-ST-Elevation myocardial infarction
Register
CARDS
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Klinikum Nürnberg
name: University Hospital Muenster
name: GlaxoSmithKline
First posted: 2010-09-09
Enrollment: 3248
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Documentation of characteristics from consecutive patients with an acute STEMI or an acute NSTEMI in hospital daily routine in Germany.
timeFrame: 10/01/2005-02/01/2009
Secondary outcomes:
measure: Documentation of acute invasive and adjuvant medical therapy of STEMI and NSTEMI in hospital daily routine in Germany
timeFrame: 10/01/2005-02/01/2009
measure: Documentation of hospital mortality and non-fatal cerebrovascular complications (stroke, re-myocardial infarction)
timeFrame: 10/01/2005-02/01/2009
measure: Documentation of medication for secondary prevention at hospital discharge
timeFrame: 10/01/2005-02/01/2009
measure: 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
timeFrame: 10/01/2005-02/01/2009
measure: Verification of the benefits of the European Standards for Data Collection for Cardiology (CARDS = Cardiology Audit and Register Standards) in daily hospital routine.
timeFrame: 10/01/2005-02/01/2009
measure: Verification of the implementation of therapy according to the guidelines for STEMI and NSTEMI patients in daily hospital routine in Germany.
timeFrame: 10/01/2005-02/01/2009
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Medizinische Klinik und Poliklinik, Universitätklinikum Münster
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd / Cardiology
Study officials:
affiliation: Stiftung Institut für Herzinfarktforschung
name: Anselm K Gitt, MD
role: STUDY_CHAIR
affiliation: Stiftung Institut für Herzinfarktforschung
name: Jochen Senges, MD
role: STUDY_CHAIR
References: