OPTAMI (Optimized Therapy of Acute Myocardial Infarction)... | NCT01197729

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

NCT01197729

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

3,248Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Sep 7, 2010

First Submission Date that Met QC Criteria

Sep 7, 2010

First Posted Date

Sep 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2024

Last Update Posted Date

Dec 20, 2024Actual

Name	Class
Klinikum Nürnberg	OTHER
University Hospital Muenster	OTHER
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,248Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STEMI		(ST-Elevation myocardial infarction)
NSTEMI		Non-ST-Elevation myocardial infarction

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anselm K Gitt, MD	Stiftung Institut für Herzinfarktforschung	Study Chair
Jochen Senges, MD	Stiftung Institut für Herzinfarktforschung	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Klinik und Poliklinik, Universitätklinikum Münster		Münster		48729	Germany
Klinikum Nürnberg Süd / Cardiology

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D000072657	ST Elevation Myocardial Infarction
D000072658	Non-ST Elevated Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided