OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry

This study has been completed.
Sponsor:
Collaborators:
Klinikum Nürnberg
University Hospital Muenster
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University Hospital Muenster
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 August 20, 2014