Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study (LE-Heart)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Leipzig.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Leipzig
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00497887
First received: July 6, 2007
Last updated: October 18, 2010
Last verified: January 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 6, 2007 | ||||||||
| Last Updated Date | October 18, 2010 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
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| Change History | Complete list of historical versions of study NCT00497887 on ClinicalTrials.gov Archive Site | ||||||||
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study | ||||||||
| Official Title ICMJE | Observational Study for Identification of Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study (LE-Heart) | ||||||||
| Brief Summary | Atherosclerotic cardiovascular disease is the major cause of morbidity and mortality in Western societies. It is a complex genetic disorder with many genes involved and significant gene-environment interactions. The aim of the study is to identify novel genetic- and biological-markers of atherosclerosis. Atherosclerosis is assessed in the coronary arteries using coronary angiography as well as in the carotid artery (intima-media-thickness) and peripheral vessels (ankle brachial index). Association analysis of genetic and metabolic markers with atherosclerotic burden will be performed to identify novel factors of disposition to atherosclerotic vascular disease. |
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| Detailed Description | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Biospecimen | Retention: Samples With DNA Description: serum, plasma, whole blood (DNA), blood cells |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients assigned to coronary angiography |
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| Condition ICMJE |
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| Publications * | Beutner F, Teupser D, Gielen S, Holdt LM, Scholz M, Boudriot E, Schuler G, Thiery J. Rationale and design of the Leipzig (LIFE) Heart Study: phenotyping and cardiovascular characteristics of patients with coronary artery disease. PLoS One. 2011;6(12):e29070. Epub 2011 Dec 22. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 4000 | ||||||||
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| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00497887 | ||||||||
| Other Study ID Numbers ICMJE | 276-2005 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Joachim Thiery, Daniel Teupser, Stephan Gielen, Gerhard Schuler, University Leipzig | ||||||||
| Study Sponsor ICMJE | University of Leipzig | ||||||||
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| Information Provided By | University of Leipzig | ||||||||
| Verification Date | January 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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