- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00196261
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Long-Term Prediction
March 9, 2018 updated by: Deutsches Herzzentrum Muenchen
The purpose of this study is to investigate the performance of established and new risk preditors in predicting long term-mortality (up to ten years) of post-infarction patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment
3500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Munich, Germany, 80636
- Deutsches Herzzentrum Muenchen
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Munich, Germany, 81675
- 1. Medizinische Klinik, Klinikum rechts der Isar
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
acute myocardial infarction
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/S0140-6736(98)08428-1.
- 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. doi: 10.1161/01.CIR.0000088783.34082.89. 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. doi: 10.1093/eurheartj/ehi188. 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. doi: 10.1093/eurheartj/ehi101. Epub 2005 Jan 26.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1995
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 20, 2005
Study Record Updates
Last Update Posted (ACTUAL)
March 12, 2018
Last Update Submitted That Met QC Criteria
March 9, 2018
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE IDE No. R00195
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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