Periodontitis and Coronary Heart Disease

May 1, 2012 updated by: Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg

Periodontitis and Its Microbiological Agents as Prognostic Factors in Patients With 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

960

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Halle (Saale), Germany, 06097
        • Martin Luther-University Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with coronary heart disease, admitted to the Martin Luther-University Halle-Wittenberg

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
coronary heart disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined endpoint: myocardial infarction, cardiovascular death, stroke
Time Frame: 12 months follow-up
12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

The German Heart Foundation

Investigators

  • Principal Investigator: Axel Schlitt, MD, Department of Medicine III, Martin Luther-University Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Estimate)

May 2, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F/34/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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