Periodontitis and Coronary Heart Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01045070|
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : May 2, 2012
"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.
|Condition or disease|
|Periodontitis Coronary Heart Disease|
|Study Type :||Observational|
|Actual Enrollment :||960 participants|
|Official Title:||Periodontitis and Its Microbiological Agents as Prognostic Factors in Patients With Coronary Heart Disease|
|Study Start Date :||October 2009|
|Primary Completion Date :||December 2010|
|Study Completion Date :||May 2012|
|coronary heart disease|
- Combined endpoint: myocardial infarction, cardiovascular death, stroke [ Time Frame: 12 months follow-up ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045070
|Martin Luther-University Halle-Wittenberg|
|Halle (Saale), Germany, 06097|
|Principal Investigator:||Axel Schlitt, MD||Department of Medicine III, Martin Luther-University Halle-Wittenberg|