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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
  Purpose

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.


Condition
Myocardial Infarction
ST-Elevation Myocardial Infarction
Non-ST-Elevation Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: OPTAMI (Optimierte Therapie Des Akuten Myokard-Infarktes) - Register

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3248
Study Start Date: October 2005
Study Completion Date: February 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
STEMI
(ST-Elevation myocardial infarction)
NSTEMI
Non-ST-Elevation myocardial infarction

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197729

Locations
Germany
Medizinische Klinik und Poliklinik, Universitätklinikum Münster
Münster, Germany, 48729
Klinikum Nürnberg Süd / Cardiology
Nürnberg, Germany, 90471
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Klinikum Nürnberg
Universitätsklinikum Münster, Medizinische Klinik und Poliklinik
GlaxoSmithKline
Investigators
Study Chair: Anselm K Gitt, MD Stiftung Institut für Herzinfarktforschung
Study Chair: Jochen Senges, MD Stiftung Institut für Herzinfarktforschung
  More Information

No publications provided

Responsible Party: Jochen Senges, MD, Stiftung Institut fuer Herzinfarktforschung (Foundation for Cardiac Infarction Research)
ClinicalTrials.gov Identifier: NCT01197729     History of Changes
Other Study ID Numbers: OPTAMI
Study First Received: September 7, 2010
Last Updated: September 7, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Myocardial infarction
ST-Elevation myocardial infarction
Non-ST-Elevation myocardial infarction
Register
CARDS

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013