AtherosclerosisLE-HeartNCT00497887
Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study
An observational study of Atherosclerosis and Coronary Arteriosclerosis, run by University of Leipzig at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atherosclerosis, Coronary Arteriosclerosis, Carotid Artery Diseases
- How many people
- 4,000 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients assigned to coronary angiography
Who may be able to join
- Patients assigned to coronary angiography
Who cannot join
- Cancer
- Acute myocardial infarction
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University of Leipzig, Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics
Leipzig, 04103
Joachim Thiery, MD PhD, +49-341-9722201, thiery@medizin.uni-leipzig.de
Daniel Teupser, MD PhD, +49-341-9722204, teupser@medizin.uni-leipzig.de
- Recruiting
University of Leipzig, Heart Center, Department of Cardiology
Leipzig, 04289
Gerhard Schuler, MD PhD, +49-341-8650
Stephan Gielen, MD PhD, +49-341-8650
About this study
Official title: Observational Study for Identification of Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study (LE-Heart)
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.
- Conditions
- Atherosclerosis, Coronary Arteriosclerosis, Carotid Artery Diseases, Genetic Predisposition to Disease, Biological Markers
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Carotid Artery Diseases, Genetic Predisposition to Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Joachim Thiery, MD PhD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497887
- Sponsor's protocol ID
- 276-2005
- Acronym
- LE-Heart
- Status last verified
- Jan 2010
- First submitted
- 6 Jul 2007
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Teren A, Netto J, Thiery J, Thiele H, Stellbrink C, Lawin D, Lawrenz T, Derda AA, Henger S, Kirsten H, Scholz M, Kaiser T. Cardiac Biomarkers to Refine Pretest Probability for Coronary Obstruction and Predict Survival After Revascularization in Chronic Coronary Syndrome. J Am Heart Assoc. 2026 Jun 2;15(11):e048737. doi: 10.1161/JAHA.125.048737. Epub 2026 May 29.
PubMed 42216272Teren 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.
PubMed 32684363Jacobi 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.
PubMed 31974565Pott 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.
PubMed 29748315Weissgerber 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.
PubMed 26362881Beutner 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.
PubMed 22216169
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Identification of Genetic- and Biological-Markers of Predisposition to Atherosclerosis: Leipzig-Heart Study (LE-Heart)
- ClinicalTrials.gov ID
- NCT00497887
- Acronym / sponsor ID
- LE-Heart / 276-2005
- Conditions
- Atherosclerosis, Coronary Arteriosclerosis, Carotid Artery Diseases, Genetic Predisposition to Disease, Biological Markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Dec 2006
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assigned to coronary angiography
Key inclusion criteria (1 listed)
- Patients assigned to coronary angiography
Key exclusion criteria (3 listed)
- Cancer
- Acute myocardial infarction
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
- Derived from this study: PubMed 42216272Teren A, Netto J, Thiery J, Thiele H, Stellbrink C, Lawin D, Lawrenz T, Derda AA, Henger S, Kirsten H, Scholz M, Kaiser T. Cardiac Biomarkers to Refine Pretest Probability for Coronary Obstruction and Predict Survival After Revascularization in Chronic Coronary Syndrome. J Am Heart Assoc. 2026 Jun 2;15(11):e048737. doi: 10.1161/JAHA.125.048737. Epub 2026 May 29.
- Derived from this study: PubMed 32684363Teren 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.
- Derived from this study: PubMed 31974565Jacobi 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.
- Derived from this study: PubMed 29748315Pott 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.
- Derived from this study: PubMed 26362881Weissgerber 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.
- Derived from this study: PubMed 22216169Beutner 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.
- University Hospital Leipzig, Institute of Laboratory Medicine, Clinical Chemistry and Molecular DiagnosticsLink provided by the sponsor.
- University of Leipzig, Heart CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Thiery, MD PhD principal investigator
University of Leipzig
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Coronary Arteriosclerosis, run by University of Leipzig at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Thiery, MD PhD (+49-341-9722201, thiery@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00497887, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.