Sweetheart-Register: Risk Management of Diabetics With Acute Myocardial Infarction

Diabetes Clinical Trial

— Sweetheart  

Official title:

Sweetheart: Risiko-Management Von Diabetikern Mit Akutem Myokardinfarkt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197742
• Other study ID #: Sweetheart
• Status: Completed
• Phase: N/A
• First received: September 7, 2010
• Last updated: September 7, 2010
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2010
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2772
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Infarction
• Myocardial Infarction
• NSTEMI
• STEMI

Locations

Country	Name	City	State
Germany	Städ Krankenhaus münchen Schwabing	München
Germany	Klinikum Nürnberg Süd /Cardiology	Nürnberg

Sponsors (2)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	Sanofi-Aventis Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany		04/01/2007-09/30/2009	No
Secondary	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	No
Secondary	Documentation of acute invasive and adjuvant medicamentous therapy of STEMI and NSREMI in hospital daily routine in Germany		04/01/2007-09/30/2009	No
Secondary	Documentation of diabetic therapy during the acute phase of a myocardial infarction		04/01/2007-09/30/2009	No
Secondary	Documentation of the hospital mortality, the serious but non-fatal complications (stroke, re-myocardial infarction) and other bleeding complications		04/01/2007-09/30/2009	No
Secondary	Verification of the implementation of a therapy according to the guidelines for STEMI / NSTEMI in daily hospital routine		04/01/2007-09/30/2009	No