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Periodontitis and Coronary Heart Disease

This study has been completed.
Sponsor:
Collaborator:
The German Heart Foundation
Information provided by (Responsible Party):
Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01045070
First received: January 7, 2010
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

"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
Periodontitis
Coronary Heart Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Periodontitis and Its Microbiological Agents as Prognostic Factors in Patients With Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Combined endpoint: myocardial infarction, cardiovascular death, stroke [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood-samples and samples from gingival pockets


Enrollment: 960
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary heart disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045070

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

No publications provided

Responsible Party: Axel Schlitt, PD Dr. med. habil., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01045070     History of Changes
Other Study ID Numbers: F/34/08
Study First Received: January 7, 2010
Last Updated: May 1, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 25, 2014