OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry

Myocardial Infarction Clinical Trial

— OPTAMI  

Official title:

OPTAMI (Optimierte Therapie Des Akuten Myokard-Infarktes) - Register

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197729
• Other study ID #: OPTAMI
• Status: Completed
• Phase: N/A
• First received: September 7, 2010
• Last updated: September 7, 2010
• Start date: October 2005
• Est. completion date: February 2010

Study information

• Verified date: September 2010
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST-Elevation Myocardial Infarction
• ST-Elevation Myocardial Infarction

Locations

Country	Name	City	State
Germany	Medizinische Klinik und Poliklinik, Universitätklinikum Münster	Münster
Germany	Klinikum Nürnberg Süd / Cardiology	Nürnberg

Sponsors (4)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	GlaxoSmithKline, Klinikum Nürnberg, University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

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