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. Identifier: NCT01045070
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : May 2, 2012
The German Heart Foundation
Information provided by (Responsible Party):
Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg

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.

Condition or disease
Periodontitis Coronary Heart Disease

Study Type : Observational
Actual Enrollment : 960 participants
Time Perspective: Prospective
Official Title: Periodontitis and Its Microbiological Agents as Prognostic Factors in Patients With Coronary Heart Disease
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

coronary heart disease

Primary Outcome Measures :
  1. Combined endpoint: myocardial infarction, cardiovascular death, stroke [ Time Frame: 12 months follow-up ]

Biospecimen Retention:   Samples With DNA
Blood-samples and samples from gingival pockets

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with coronary heart disease, admitted to the Martin Luther-University Halle-Wittenberg

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01045070

Martin Luther-University Halle-Wittenberg
Halle (Saale), Germany, 06097
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
The German Heart Foundation
Principal Investigator: Axel Schlitt, MD Department of Medicine III, Martin Luther-University Halle-Wittenberg

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Axel Schlitt, PD Dr. med. habil., Martin-Luther-Universität Halle-Wittenberg Identifier: NCT01045070     History of Changes
Other Study ID Numbers: F/34/08
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Keywords provided by Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg:
periodontitis and coronary heart disease

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Vascular Diseases
Arterial Occlusive Diseases