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OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry

This study has been completed.
Sponsor:
Collaborators:
Klinikum Nürnberg
Universitätsklinikum Münster, Medizinische Klinik und Poliklinik
GlaxoSmithKline
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197729
First received: September 7, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 7, 2010
September 7, 2010
October 2005
February 2009   (final data collection date for primary outcome measure)
Documentation of characteristics from consecutive patients with an acute STEMI or an acute NSTEMI in hospital daily routine in Germany. [ Time Frame: 10/01/2005-02/01/2009 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Documentation of acute invasive and adjuvant medical therapy of STEMI and NSTEMI in hospital daily routine in Germany [ Time Frame: 10/01/2005-02/01/2009 ] [ Designated as safety issue: No ]
  • Documentation of hospital mortality and non-fatal cerebrovascular complications (stroke, re-myocardial infarction) [ Time Frame: 10/01/2005-02/01/2009 ] [ Designated as safety issue: No ]
  • Documentation of medication for secondary prevention at hospital discharge [ Time Frame: 10/01/2005-02/01/2009 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 10/01/2005-02/01/2009 ] [ Designated as safety issue: No ]
  • Verification of the benefits of the European Standards for Data Collection for Cardiology (CARDS = Cardiology Audit and Register Standards) in daily hospital routine. [ Time Frame: 10/01/2005-02/01/2009 ] [ Designated as safety issue: No ]
  • Verification of the implementation of therapy according to the guidelines for STEMI and NSTEMI patients in daily hospital routine in Germany. [ Time Frame: 10/01/2005-02/01/2009 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry
OPTAMI (Optimierte Therapie Des Akuten Myokard-Infarktes) - Register

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic
  • Myocardial Infarction
  • ST-Elevation Myocardial Infarction
  • Non-ST-Elevation Myocardial Infarction
Not Provided
  • STEMI
    (ST-Elevation myocardial infarction)
  • NSTEMI
    Non-ST-Elevation myocardial infarction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3248
February 2010
February 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01197729
OPTAMI
No
Jochen Senges, MD, Stiftung Institut fuer Herzinfarktforschung (Foundation for Cardiac Infarction Research)
Stiftung Institut fuer Herzinfarktforschung
  • Klinikum Nürnberg
  • Universitätsklinikum Münster, Medizinische Klinik und Poliklinik
  • GlaxoSmithKline
Study Chair: Anselm K Gitt, MD Stiftung Institut für Herzinfarktforschung
Study Chair: Jochen Senges, MD Stiftung Institut für Herzinfarktforschung
Stiftung Institut fuer Herzinfarktforschung
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP