Skip to content

Periodontitis and Coronary Heart Disease

Periodontitis and Its Microbiological Agents as Prognostic Factors in Patients With Coronary Heart Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01045070
Enrollment
960
Registered
2010-01-08
Start date
2009-10-31
Completion date
2012-05-31
Last updated
2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Periodontitis

Keywords

periodontitis and coronary heart disease

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.

Interventions

None listed

Sponsors

The German Heart Foundation
CollaboratorOTHER
Martin-Luther-Universität Halle-Wittenberg
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
Combined endpoint: myocardial infarction, cardiovascular death, stroke12 months follow-up

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026