NCT04719026

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2018Mar 2027

Study Start

First participant enrolled

February 16, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

9.1 years

First QC Date

January 18, 2021

Last Update Submit

May 4, 2026

Conditions

Keywords

myocardial infarctioncoronary artery diseaseperiodontal diseases

Outcome Measures

Primary Outcomes (1)

  • Prevalence of periodontitis

    Our primary objective is the description of periodontal health in patients admitted with acute myocardial infarction compared to matched controls

    Single point examination

Study Arms (2)

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

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

Interventions

It is an observational study to investigate the prevalence of periodontitis in cases and controls.

CasesControls

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Karolin Hijazi

Aberdeen, AB25 2ZR, United Kingdom

RECRUITING

Related Publications (1)

  • Joshi C, Mezincescu A, Gunasekara M, Rudd A, Botchorichvili H, Sabir S, Dospinescu C, Noman A, Hogg D, Cherukara G, McLernon D, Hijazi K, Dawson D. Myocardial infarction risk is increased by periodontal pathobionts: a cross-sectional study. Sci Rep. 2022 Nov 3;12(1):18608. doi: 10.1038/s41598-022-19154-z.

Biospecimen

Retention: SAMPLES WITH DNA

subgingival plaque samples, saliva, blood, and in a subgroup of Mi patients (n=10) aspirated intracoronary thrombi and stent deployment ballons used during a primary percutaneous intervention procedure

MeSH Terms

Conditions

Myocardial InfarctionPeriodontitisCoronary Artery DiseasePeriodontal Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisMouth DiseasesStomatognathic DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 22, 2021

Study Start

February 16, 2018

Primary Completion (Estimated)

March 14, 2027

Study Completion (Estimated)

March 14, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations