Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by:

Deutsches Herzzentrum Muenchen

ClinicalTrials.gov Identifier:

NCT00196235

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Purpose

The purpose of this study was to evaluate the performance of established and new risk predictors in predicting mortality in post-infarction patients suffering from diabetes mellitus

Condition
Myocardial Infarction

Study Type:	Observational
Study Design:	Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective
Official Title:	Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Diabetes Mellitus

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Heart Attack

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Estimated Enrollment:	650
Study Start Date:	January 1995

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

acute myocardial infarction, presence of sinusrhythm

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196235

Locations

Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:	Georg Schmidt, MD	Deutsches Herzzentrum Muenchen
Study Director:	Petra Barthel, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Axel Bauer, MD	Deutsches Herzzentrum Muenchen

More Information

Additional Information:

heart rate turbulence home page This link exits the ClinicalTrials.gov site

Publications:

Barthel P, Schneider R, Bauer A, Ulm K, Schmitt C, Schomig A, Schmidt G. Risk stratification after acute myocardial infarction by heart rate turbulence. Circulation. 2003 Sep 9;108(10):1221-6. Epub 2003 Aug 25.

Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. Epub 2005 Mar 18.

Bauer A, Guzik P, Barthel P, Schneider R, Ulm K, Watanabe MA, Schmidt G. Reduced prognostic power of ventricular late potentials in post-infarction patients of the reperfusion era. Eur Heart J. 2005 Apr;26(8):755-61. Epub 2005 Jan 26.

Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6.

ClinicalTrials.gov Identifier:	NCT00196235 History of Changes
Other Study ID Numbers:	GE IDE No. R00295
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:

Assessment, Risk
Diabetes mellitus
Autonomic nervous system

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 October 16, 2012

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