NCT01045070

Brief Summary

"Atherosclerosis is an inflammatory disease". The hypothesis of an infectious burden as trigger or initiator of the inflammatory process in atherosclerosis has been extensively discussed in the past years. One part of this discussion is focused on the infectious agents responsible for periodontitis. Several studies have found an association of periodontitis and/or bacteria related to this disease and atherosclerosis. However, a study focussing on the prognostic relevance of these factors is missing. The hypothesis of this study is that periodontitis is a prognostic relevant risk factor for patients with angiographically proven coronary heart disease. Furthermore, the infectious pathogen burden by PCR-detection of periodontal pathogens will be evaluated as a prognostic factor. 960 consecutive patients with angiographically proven coronary heart disease will be included in this study. After inclusion of patients an extensive periodontal examination including PCR-sampling for 11 bacteria (Porphyromonas gingivitis, Actinobacillus actinomycetemcomitans, and others) will be performed. After 12 months patient will be follow up for any major adverse events (cardiovascular death, myocardial infarction, stroke). If this study will find a relation of periodontitis or its microbiological agents to cardiovascular outcome of patients with coronary heart disease, further studies are necessary to investigate potential therapeutic consequences for patients with CHD and periodontitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

January 7, 2010

Last Update Submit

May 1, 2012

Conditions

PeriodontitisCoronary Heart Disease

Keywords

periodontitis and coronary heart disease

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint: myocardial infarction, cardiovascular death, stroke

    12 months follow-up

Study Arms (1)

coronary heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with coronary heart disease, admitted to the Martin Luther-University Halle-Wittenberg

You may qualify if:

  • Age \>18 years
  • Coronary heart disease as defined by previous or current detection of 50% stenosis of a main coronary artery by coronary angiography or previous or current percutaneous coronary intervention (PCI) or previous or current coronary artery bypass surgery (CABG)

You may not qualify if:

  • Inability to give written informed consent
  • Periodontal treatment and/or antibiotic therapy during the last 6 months
  • Pregnancy
  • Current alcohol or drug abuse, or psychological reasons that make study participation impractical
  • Drugs which are potential causal for gingival hyperplasia (Hydantoin, Nifedipine, Cyclosporin A, and other)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martin Luther-University Halle-Wittenberg

Halle, 06097, Germany

Location

Related Publications (8)

  • Reichert S, Rehm S, Schlitt A, Schulz S. Severe Periodontitis is Associated With Recurrent Cardiovascular Events-A 10-Year Longitudinal Cohort Study. J Periodontal Res. 2024 Nov 22. doi: 10.1111/jre.13365. Online ahead of print.

    PMID: 39578376DERIVED

  • Schulz S, Rehm S, Schlitt A, Bitter K, Reichert S. The Interleukin 6 Protein Level as well as a Genetic Variants, (rs1800795, rs1800797) Are Associated with Adverse Cardiovascular Outcomes within 10-Years Follow-Up. Cells. 2023 Nov 28;12(23):2722. doi: 10.3390/cells12232722.

    PMID: 38067150DERIVED

  • Schulz S, Rehm S, Schlitt A, Lierath M, Ludike H, Hofmann B, Bitter K, Reichert S. C-Reactive Protein Level and the Genetic Variant rs1130864 in the CRP Gene as Prognostic Factors for 10-Year Cardiovascular Outcome. Cells. 2023 Jul 4;12(13):1775. doi: 10.3390/cells12131775.

    PMID: 37443809DERIVED

  • Schulz S, Zielske M, Schneider S, Hofmann B, Schaller HG, Schlitt A, Reichert S. Polymorphism of CD14 Gene Is Associated with Adverse Outcome among Patients Suffering from Cardiovascular Disease. Mediators Inflamm. 2021 Jul 8;2021:3002439. doi: 10.1155/2021/3002439. eCollection 2021.

    PMID: 34305452DERIVED

  • Reichert S, Seitter L, Schaller HG, Schlitt A, Schulz S. ANRIL polymorphisms (rs1333049 and rs3217992) in relation to plasma CRP levels among in-patients with CHD. Cytokine. 2020 Mar;127:154932. doi: 10.1016/j.cyto.2019.154932. Epub 2019 Nov 27.

    PMID: 31770616DERIVED

  • Schulz S, Schlitt A, Hofmann B, Schaller HG, Reichert S. Periodontal pathogens and their role in cardiovascular outcome. J Clin Periodontol. 2020 Feb;47(2):173-181. doi: 10.1111/jcpe.13224. Epub 2019 Dec 16.

    PMID: 31765020DERIVED

  • Reichert S, Schlitt A, Benten AC, Hofmann B, Schaller HG, Schulz S. Data on IL-6 c.-174 G>C genotype and allele frequencies in patients with coronary heart disease in dependence of cardiovascular outcome. Data Brief. 2016 Jul 16;8:1295-9. doi: 10.1016/j.dib.2016.07.020. eCollection 2016 Sep.

    PMID: 27570807DERIVED

  • Schulz S, Schlitt A, Lutze A, Lischewski S, Seifert T, Dudakliewa T, Gawe R, Werdan K, Hofmann B, Glaser C, Schaller HG, Reichert S. The importance of genetic variants in TNFalpha for periodontal disease in a cohort of coronary patients. J Clin Periodontol. 2012 Aug;39(8):699-706. doi: 10.1111/j.1600-051X.2012.01909.x. Epub 2012 Jun 12.

    PMID: 22691114DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood-samples and samples from gingival pockets

MeSH Terms

Conditions

PeriodontitisCoronary Disease

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Axel Schlitt, MD

    Department of Medicine III, Martin Luther-University Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. habil.

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 8, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

May 1, 2012

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations

DE(1)