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临床试验/NCT01045070
NCT01045070已完成不适用

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

Martin-Luther-Universität Halle-Wittenberg1 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
960
试验地点
1
主要终点
Combined endpoint: myocardial infarction, cardiovascular death, stroke

研究概览

简要总结

"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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

结局指标

主要结局

Combined endpoint: myocardial infarction, cardiovascular death, stroke

时间窗: 12 months follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Axel Schlitt

PD Dr. med. habil.

Martin-Luther-Universität Halle-Wittenberg

研究点 (1)

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