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

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Aventis Deutschland GmbH
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197742
First received: September 7, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition
Diabetes
STEMI
NSTEMI
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sweetheart: Risiko-Management Von Diabetikern Mit Akutem Myokardinfarkt

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany [ Time Frame: 04/01/2007-09/30/2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 04/01/2007-09/30/2009 ] [ Designated as safety issue: No ]
  • Documentation of acute invasive and adjuvant medicamentous therapy of STEMI and NSREMI in hospital daily routine in Germany [ Time Frame: 04/01/2007-09/30/2009 ] [ Designated as safety issue: No ]
  • Documentation of diabetic therapy during the acute phase of a myocardial infarction [ Time Frame: 04/01/2007-09/30/2009 ] [ Designated as safety issue: No ]
  • Documentation of the hospital mortality, the serious but non-fatal complications (stroke, re-myocardial infarction) and other bleeding complications [ Time Frame: 04/01/2007-09/30/2009 ] [ Designated as safety issue: No ]
  • Verification of the implementation of a therapy according to the guidelines for STEMI / NSTEMI in daily hospital routine [ Time Frame: 04/01/2007-09/30/2009 ] [ Designated as safety issue: No ]

Enrollment: 2772
Study Start Date: October 2007
Study Completion Date: September 2009
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197742

Locations
Germany
Städ Krankenhaus münchen Schwabing
München, Germany, 80804
Klinikum Nürnberg Süd /Cardiology
Nürnberg, Germany, 90471
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Sanofi-Aventis Deutschland GmbH
Investigators
Study Chair: Anselm K Gitt, MD Stiftung Institut für Herzinfarktforschung
Study Chair: Jochen Senges, MD Stiftung Institut für Herzinfarktforschung
  More Information

No publications provided

Responsible Party: Jochen Senges, MD, Stiftung Institut fuer Herzinfarktforschung (Foundation for Cardiac Infarction Research)
ClinicalTrials.gov Identifier: NCT01197742     History of Changes
Other Study ID Numbers: Sweetheart
Study First Received: September 7, 2010
Last Updated: September 7, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Diabetes
STEMI
NSTEMI
Myocardial infarction

Additional relevant MeSH terms:
Diabetes Mellitus
Infarction
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
 Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013