Periodontitis and Coronary Heart Disease
"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.
Coronary Heart Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||Periodontitis and Its Microbiological Agents as Prognostic Factors in Patients With Coronary Heart Disease|
- Combined endpoint: myocardial infarction, cardiovascular death, stroke [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood-samples and samples from gingival pockets
|Study Start Date:||October 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|coronary heart disease|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045070
|Martin Luther-University Halle-Wittenberg|
|Halle (Saale), Germany, 06097|
|Principal Investigator:||Axel Schlitt, MD||Department of Medicine III, Martin Luther-University Halle-Wittenberg|