Observational Study of the Association Between Periodontal Disease and Cardiovascular Disease

NCT02177591 | Completed

• 1 other identifier: L14-141
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of cardiovascular disease is rising; new methods must be created to assess the cardiovascular status of patients. If cardiovascular disease can be predicted, it may facilitate prevention. An association between periodontal disease and cardiovascular has been established, but a definitive mechanism is not understood. A good first step in finding that mechanism is to look at the correlation between periodontal disease and cardiovascular disease, both of which have an inflammatory component. This study observes the level of cardiovascular disease in patients and correlates it with the presence and degree of periodontal pathogens.

Conditions

Periodontal Disease; Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Comparing level of coronary artery disease with amount of bacteria in the mouth

  Will compare patients in each group with the numerical value of P. gingivalis and A. actinomycetemcomitans in the mouth.

  Baseline

• Compare level of hs-CRP with level of bacteria

  Will compare levels of hs-CRP (mg/dL) in the blood with the numerical value of P. gingivalis and A. actinomycetemcomitans in the mouth.

  Baseline

• Compare levels of IL-6 with level of bacteria

  Will compare levels of IL-6 (pg/mL) in the blood with the numerical value of P. gingivalis and A. actinomycetemcomitans in the mouth.

  Baseline

Study Arms (3)

CAD and MI

Patients with a history of coronary artery disease who have had a myocardial infarction in the past.

CAD, no MI

Patients who have a history of coronary artery disease and have not had a myocardial infarction in the past.

no CAD

Patients with no documented history of coronary artery disease.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients from ages 18-89 years who are being seen in the Cardiology clinic at TTUHSC who meet inclusion and exclusion criteria, and who will consent to participating in the study. There will be 20 to 30 patients in each group.

You may qualify if:

• Patients with known CAD with and without previous MI, OR
• Patients with no known CAD
• Ages 18-89 years

You may not qualify if:

• Patients with a known history of rheumatoid arthritis.
• Patients with a known history of lupus.
• Patients currently under the care of a rheumatologist.
• Patients who have had a MI in the two weeks prior to entering the study.
• Patients with a previous history of coronary artery bypass graft.
• Patients who have taken antibiotics in the two weeks prior to entering the study.
• Patients who are unable to provide at least 2 out of the 3 gingival samples.
• Current smokers.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Periodontal Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Scott Shurmur, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)