Myocardial Infarction Register of the Saarland | NCT02961985

Studies
Myocardial Infarction Register of the Saarland

NCT02961985

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Status

Completed

Last Update Posted

Apr 14, 2023Actual

Enrollment

455Actual

Phase

Not provided

Conditions

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

Apr 2023

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 2016Actual

Primary Completion Date

Jul 19, 2018Actual

Completion Date

Mar 29, 2023Actual

First Submitted Date

Sep 5, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 11, 2016Estimated

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

Apr 11, 2023

Last Update Posted Date

Apr 14, 2023Actual

Name	Class
Ministry of Social Affairs, Health, Women and Family of Saarland	UNKNOWN

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

The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to provide current data on the implementation of guidelines for both, the interventional and adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.

Detailed Description

In order to obtain representative data for the Saarland, preferably all consecutive patients should be documented comprehensively in the University Hospital of the Saarland, the non-university hospitals with cardiac catheterization laboratory as well as in hospitals without cardiac catheterization laboratory .

MIR-SL is attended by all 22 hospitals in Saarland, that treat patients with acute STEMI. A follow-up will be carried out after three months, 12 months and five years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

455Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of reperfusion therapies	Describe hospital daily routine in Germany	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Time before reperfusion therapy	pre-hospital time, intrahospital time, transfer time	24 hours
In-hospital mortality	Describe mortality before discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed informed consent

Exclusion Criteria:

age < 18 years
missing informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to a hospital in the Saarland region with ST elevation myocardial infarction, in the last 24 hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anselm K. Gitt, Dr.	Stiftung Institut fuer Herzinfarktforschung	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Saarbruecken		Saarbrücken	Saarland	66119	Germany
Marienhaus Klinikum Saarlouis-Dillingen

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	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