NCT01197729

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

3.3 years

First QC Date

September 7, 2010

Last Update Submit

December 18, 2024

Conditions

Myocardial InfarctionST-Elevation Myocardial InfarctionNon-ST-Elevation Myocardial Infarction

Keywords

Myocardial infarctionST-Elevation myocardial infarctionNon-ST-Elevation myocardial infarctionRegisterCARDS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Documentation of acute invasive and adjuvant medical therapy of STEMI and NSTEMI in hospital daily routine in Germany

    10/01/2005-02/01/2009

  • Documentation of hospital mortality and non-fatal cerebrovascular complications (stroke, re-myocardial infarction)

    10/01/2005-02/01/2009

  • Documentation of medication for secondary prevention at hospital discharge

    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

    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.

    10/01/2005-02/01/2009

  • +1 more secondary outcomes

Study Arms (2)

STEMI

(ST-Elevation myocardial infarction)

NSTEMI

Non-ST-Elevation myocardial infarction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medizinische Klinik und Poliklinik, Universitätklinikum Münster

Münster, 48729, Germany

Location

Klinikum Nürnberg Süd / Cardiology

Nuremberg, 90471, Germany

Location

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Anselm K Gitt, MD

    Stiftung Institut für Herzinfarktforschung

    STUDY CHAIR

  • Jochen Senges, MD

    Stiftung Institut für Herzinfarktforschung

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

October 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2010

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations

DE(2)