Myocardial InfarctionOPTAMINCT01197729
OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry
An observational study of Myocardial Infarction and ST-Elevation Myocardial Infarction, run by Stiftung Institut fuer Herzinfarktforschung at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, ST-Elevation Myocardial Infarction, Non-ST-Elevation Myocardial Infarction
- How many people
- 3,248 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2005to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- missing informed consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medizinische Klinik und Poliklinik, Universitätklinikum Münster
Münster, 48729
Klinikum Nürnberg Süd / Cardiology
Nuremberg, 90471
About this study
Official title: 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.
- Conditions
- Myocardial Infarction, ST-Elevation Myocardial Infarction, Non-ST-Elevation Myocardial Infarction
- Keywords
- Myocardial infarction, ST-Elevation myocardial infarction, Non-ST-Elevation myocardial infarction, Register, CARDS
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI | (ST-Elevation myocardial infarction) | |
| NSTEMI | Non-ST-Elevation myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of characteristics from consecutive patients with an acute STEMI or an acute NSTEMI in hospital daily routine in Germany.
Measured: 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
Measured: 10/01/2005-02/01/2009
Documentation of hospital mortality and non-fatal cerebrovascular complications (stroke, re-myocardial infarction)
Measured: 10/01/2005-02/01/2009
Documentation of medication for secondary prevention at hospital discharge
Measured: 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
Measured: 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.
Measured: 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.
Measured: 10/01/2005-02/01/2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startOct 2005
- Primary completionFeb 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Nürnberg, University Hospital Muenster, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Anselm K Gitt, MD, Study chair, Stiftung Institut für HerzinfarktforschungJochen Senges, MD, Study chair, Stiftung Institut für Herzinfarktforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197729
- Sponsor's protocol ID
- OPTAMI
- Acronym
- OPTAMI
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2010
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTAMI (Optimierte Therapie Des Akuten Myokard-Infarktes) - Register
- ClinicalTrials.gov ID
- NCT01197729
- Acronym / sponsor ID
- OPTAMI / OPTAMI
- Conditions
- Myocardial Infarction, ST-Elevation Myocardial Infarction, Non-ST-Elevation Myocardial Infarction
- Keywords
- Myocardial infarction, ST-Elevation myocardial infarction, Non-ST-Elevation myocardial infarction, Register, CARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,248 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Klinikum Nürnberg, University Hospital Muenster, GlaxoSmithKline
- Study start
- Oct 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | –(ST-Elevation myocardial infarction) |
| NSTEMI | – | –Non-ST-Elevation myocardial infarction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
Documentation of hospital mortality and non-fatal cerebrovascular complications (stroke, re-myocardial infarction)
Time frame: 10/01/2005-02/01/2009
Documentation of medication for secondary prevention at hospital discharge
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anselm K Gitt, MD study chair
Stiftung Institut für Herzinfarktforschung
Jochen Senges, MD study chair
Stiftung Institut für Herzinfarktforschung
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and ST-Elevation Myocardial Infarction, run by Stiftung Institut fuer Herzinfarktforschung at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.