CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 960 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01045070
NCT01045070N/ACompleted

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

Martin-Luther-Universität Halle-Wittenberg·observational·Posted Jan 8, 2010·Updated May 2, 2012

In Brief

An observational study for Periodontitis and Coronary Heart Disease. Completed, enrolled 960 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2010
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2010
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.5 years ago