Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Female Patients

This study has been completed.

Sponsor:

Information provided by:

Deutsches Herzzentrum Muenchen

ClinicalTrials.gov Identifier:

NCT00196287

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Purpose

The purpose of this study was to investigate differences in risk prediction in female post-infarction patients.

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): Female Patients

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Estimated Enrollment:	750
Study Start Date:	January 1995

Eligibility

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

Criteria

Inclusion Criteria:

acute myocardial infarction; female gender

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196287

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:	NCT00196287 History of Changes
Other Study ID Numbers:	GE IDE No. R00395
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
autonomic nervous system
Gender

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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