OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry (OPTAMI)

September 7, 2010 updated by: Stiftung Institut fuer Herzinfarktforschung

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, 48729
        • Medizinische Klinik und Poliklinik, Universitätklinikum Münster
      • Nürnberg, Germany, 90471
        • Klinikum Nürnberg Süd / Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
STEMI
(ST-Elevation myocardial infarction)
NSTEMI
Non-ST-Elevation myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10/01/2005-02/01/2009

Secondary Outcome Measures

Outcome Measure
Time Frame
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
10/01/2005-02/01/2009
Documentation of hospital mortality and non-fatal cerebrovascular complications (stroke, re-myocardial infarction)
Time Frame: 10/01/2005-02/01/2009
10/01/2005-02/01/2009
Documentation of medication for secondary prevention at hospital discharge
Time Frame: 10/01/2005-02/01/2009
10/01/2005-02/01/2009
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
10/01/2005-02/01/2009
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
10/01/2005-02/01/2009
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
10/01/2005-02/01/2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Collaborators

GlaxoSmithKline
University Hospital Muenster
Klinikum Nürnberg

Investigators

  • Study Chair: Anselm K Gitt, MD, Stiftung Institut für Herzinfarktforschung
  • Study Chair: Jochen Senges, MD, Stiftung Institut für Herzinfarktforschung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 9, 2010

Last Update Submitted That Met QC Criteria

September 7, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTAMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe