PERIODONTAL HEALTH IN PATIENTS ACUTELY ADMITTED FOR MYOCARDIAL INFARCTION: A CASE CONTROL STUDY (PEDICAD)

January 18, 2021 updated by: University of Aberdeen

Heart attack remains a major cause of death in adult population worldwide and especially within Scotland. A large portion of the general population has an increased risk of suffering from a heart attack because of their genetic make-up, disease profile and lifestyle choices.

Literature suggests that apart from these known risk factors, long-standing inflammation (reaction of tissues to infection or injury) elsewhere in the body may be responsible for heart attacks. It has been suggested that gum disease may be one such condition. If left untreated, gum disease may expose the entire body to a long-term inflammatory burden where inflammatory molecules can disseminate from the gums into the bloodstream and affect various body structures. This study explores the influence of gum disease on the risk of heart attack by comparing the gum health of participants who recently had a heart attack to the gum health of participants with no history of heart problems after accounting for other risk factors. Findings will provide critical information for the design of our forthcoming study to establish the effect of treatment of gum disease on the risk of heart attack, and its cost-effectiveness. Ultimately this research will tackle another risk factor for heart attacks and thus inform enhancement of public health prevention strategies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary artery disease (CAD) is a multifactorial condition leading to most cases of myocardial infarction and results from interaction of genetic, lifestyle and environmental factors. However, as many as 50% of CAD patients lack classical risk factors of CAD suggesting the presence of other contributory mechanisms. Inflammation plays a central role in the initiation and growth of the plaques which form in the arteries (atherosclerosis) and lead to CAD3. As such periodontal disease, an inflammatory process leading to progressive destruction of tooth-supporting structures, has been associated with CAD. In vivo pre-clinical studies have shown that bacteria associated with periodontal disease can exacerbate atherosclerosis 7. Numerous clinical studies have explored the association between periodontal disease and CAD at different follow-up times following episodes of myocardial infarction 8-9. However, there are no reports investigating this association during the acute phase of myocardial infarction. In addition the need for rigorous matching of all known CAD risk factors in case control studies has so far been overseen.

RATIONALE FOR STUDY:

This case-control study aims to compare the health of tooth supporting structures (periodontium) in patients hospitalised for acute myocardial infarction to a control group of patients rigorously matched for known CAD risk factors, age and gender.

Study Type

Observational

Enrollment (Anticipated)

320

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

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients for the case study group will be recruited from those hospitalized for acute myocardial infarction on the Cardiology Ward and Coronary Care Unit at Aberdeen Royal Infirmary.

A control group of dental patients matched for age (±7 years), gender, and risk factors for CAD (hypertension, obesity, diabetes, smoking, hypercholesterolemia, and family history) but with no history of myocardial infarction will be selected at Aberdeen Dental School or from the SHARE register or via the NHS Research Scotland Primary Care Network

Description

Inclusion Criteria:

  • cases: Patients aged 20-90 admitted with acute myocardial infarction
  • controls: Dental patients, aged 20-90, matched to patients in the case study group for age, gender (±7) and risk factors for coronary artery disease (hypertension, obesity, diabetes, smoking, hypercholesterolaemia) but with no history of myocardial infarction)

Exclusion Criteria:

  • Severe co-morbidities, Inability to consent, pregnant participants will be excluded, participants with other systemic inflammatory diseases, patients taking antimicrobials or antibiotics in last three years, patients taking medications, such as cyclosporine, calcium channel blockers, phenytoin, immunocompromised patients, patients with malignancies, patinets with type-2 or type-3 hypersensitivities

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Patients for the case study group will be recruited from those hospitalized for acute myocardial infarction on the Cardiology Ward and Coronary Care Unit at Aberdeen Royal Infirmary. All patients will be diagnosed using current clinical criteria for type-1 myocardial infarction according to the ESC guidelines10 and recruited within 3 days of admission. Recruitment of this arm is now complete.
Other: Full-mouth periodontal examination using computerised Florida probe
It is an observational study to investigate the prevalence of periodontitis in cases and controls.
Controls
A control group of dental patients matched for age (±3 years), gender, and risk factors for CAD (hypertension, obesity, diabetes, smoking, hypercholesterolaemia and family history) but with no history of myocardial infarction will be selected at Aberdeen Dental School or from the SHARE register or via the NHS Research Scotland Primary Care Network on an invitation basis. Thr recruitment of this arm of the study is ongoing.
Other: Full-mouth periodontal examination using computerised Florida probe
It is an observational study to investigate the prevalence of periodontitis in cases and controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of periodontitis
Time Frame: Single point examination
Our primary objective is the description of periodontal health in patients admitted with acute myocardial infarction compared to matched controls
Single point examination

Collaborators and Investigators

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

Sponsor

University of Aberdeen

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 (Actual)

February 16, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 203623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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