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

This study has been completed.

Sponsored by:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00196235

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

MedlinePlus related topics: Diabetes Heart Attack

U.S. FDA Resources

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

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

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

Publications of Results:

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.

Other Publications:

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.

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

Keywords provided by Deutsches Herzzentrum Muenchen:

Assessment, Risk
Diabetes mellitus
Autonomic nervous system

Study placed in the following topic categories:

Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Ischemia

Necrosis
Endocrinopathy
Infarction
Glucose Metabolism Disorders
Metabolic disorder
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009