Sweetheart-Register: Risk Management of Diabetics with Ac... | NCT01197742

Studies
Sweetheart-Register: Risk Management of Diabetics with Acute Myocardial Infarction

NCT01197742

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

2,772Actual

Phase

Not provided

Conditions

Diabetes
STEMI
NSTEMI
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

Apr 20, 2007Actual

Primary Completion Date

Oct 5, 2009Actual

Completion Date

Oct 5, 2009Actual

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
Sanofi	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

The Sweetheart register (Risk management of Diabetics with acute myocardial infarction) documents both the prevalence of pathologic glucose metabolism in consecutive high-risk patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute and long-term therapy. Furthermore the register will provide data about the implementation of new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.

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

2,772Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany		04/01/2007-09/30/2009

Secondary Outcomes

Measure	Description	Time Frame
Documentation of the fraction of patients with (I) a previous know Diabetes Mellitus (DM) type I and II, (II) a newly diagnosed DM, (III) diagnosed with IFG or IGT for the first time		04/01/2007-09/30/2009
Documentation of acute invasive and adjuvant medicamentous therapy of STEMI and NSREMI in hospital daily routine in Germany

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction
consecutive patients with acute (no older than 24 h) Non-ST-Elevation Myocardial infarction

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

all consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction or acute (no older than 24 h) Non-ST-Elevation Myocardial infarction.

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
Städ Krankenhaus münchen Schwabing		München		80804	Germany
Klinikum Nürnberg Süd /Cardiology

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D000072657	ST Elevation Myocardial Infarction
D000072658	Non-ST Elevated Myocardial Infarction
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided