Clinical trial NCT00497887: Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study
Official title: Observational Study for Identification of Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study (LE-Heart)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Coronary Arteriosclerosis
Carotid Artery Diseases
Genetic Predisposition to Disease
Biological Markers
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2007-07-09
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients assigned to coronary angiography

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.


Eligibility criteria: Inclusion Criteria:

* Patients assigned to coronary angiography

Exclusion Criteria:

* Cancer
* Acute myocardial infarction
* Inability to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Department of Cardiology
Study officials:
affiliation: University of Leipzig
name: Joachim Thiery, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teren A, Vogel A, Beutner F, Gielen S, Burkhardt R, Scholz M, Thiery J, Ceglarek U. Relationship between fermented dairy consumption, circulating short-chain acylcarnitines and angiographic severity of coronary artery disease. Nutr Metab Cardiovasc Dis. 2020 Sep 24;30(10):1662-1672. doi: 10.1016/j.numecd.2020.05.031. Epub 2020 Jun 8.
citation: Jacobi T, Massier L, Kloting N, Horn K, Schuch A, Ahnert P, Engel C, Loffler M, Burkhardt R, Thiery J, Tonjes A, Stumvoll M, Bluher M, Doxiadis I, Scholz M, Kovacs P. HLA Class II Allele Analyses Implicate Common Genetic Components in Type 1 and Non-Insulin-Treated Type 2 Diabetes. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgaa027. doi: 10.1210/clinem/dgaa027.
citation: Pott J, Schlegel V, Teren A, Horn K, Kirsten H, Bluecher C, Kratzsch J, Loeffler M, Thiery J, Burkhardt R, Scholz M. Genetic Regulation of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Plasma Levels and Its Impact on Atherosclerotic Vascular Disease Phenotypes. Circ Genom Precis Med. 2018 May;11(5):e001992. doi: 10.1161/CIRCGEN.117.001992.
citation: Weissgerber A, Scholz M, Teren A, Sandri M, Teupser D, Gielen S, Thiery J, Schuler G, Beutner F. The value of noncoronary atherosclerosis for identifying coronary artery disease: results of the Leipzig LIFE Heart Study. Clin Res Cardiol. 2016 Feb;105(2):172-81. doi: 10.1007/s00392-015-0900-x. Epub 2015 Sep 11.
citation: 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. doi: 10.1371/journal.pone.0029070. Epub 2011 Dec 22.