Periodontal Disease, Inflammation and Acute Coronary Syndromes

Summary

Recent studies have shown that the systemic inflammation caused by periodontal disease (PD) can determine important changes in the coronary arteries, favoring atherosclerosis progression and development of acute coronary syndromes (ACS). The aim of ATHERODENT study is to assess the interrelation between PD, inflammation and progression of coronary atherosclerosis in patients with ACS. Material and methods: This case-control observational study will enroll 100 patients (group 1 - ACS and associated PD, and group 2 -ACS and no PD), in whom the following data will be collected: (1) demographic and clinical data, (2) cardiovascular risk factors, (3) full characterization of PD markers, (4) systemic inflammatory biomarkers, (5) imaging biomarkers derived from transthoracic echocardiography, computed tomography, coronary angiography, optical coherence tomography and intravascular ultrasound, and (6) assessment of the presence of specific oral bacteria in samples of coronary plaques collected by coronary atherectomy, which will be performed during percutaneous revascularization interventions, when indicated in selected cases, in the atherectomy sub-study. The follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months. The primary endpoint of the study will be represented by the rate of major adverse cardiovascular events (MACE rates) in PD vs non-PD patients and in correlation with: (1) the level of systemic inflammation triggered by PD and/or by ACS at baseline; (2) the vulnerability degree of atheromatous plaques in the coronary tree (culprit and non-culprit lesions); and (3) the presence and burden of oral bacteria in atheromatous plaques. Secondary endpoints will be represented by: (1) the rate of progression of vulnerability degree of non-culprit coronary plaques; (2) the rate of progression of atheromatous burden and calcium scoring of the coronary tree; and (3) the rate of occurrence of left ventricular remodeling and postinfarction heart failure.

Conditions

• Coronary Stenosis
• Periodontal Diseases
• Acute Coronary Syndrome
• Non-ST Elevation Myocardial Infarction
• Unstable Angina
• Acute Myocardial Infarction
• Atherosclerosis
• Atheromatous Plaques

Interventions

DIAGNOSTIC_TEST

cardiac imaging tests

cardiac computed tomography, echocardiography, intravascular ultrasound, optical coherence tomography

Sponsors & Collaborators

• University of Targu Mures, Romania

  collaborator OTHER

• University Hospital of Targu Mures, Romania

  collaborator OTHER

• Cardio Med Medical Center

  lead INDUSTRY

Principal Investigators

• Theodora Benedek, Prof · University of Medicine and Pharmacy Tirgu Mures, CardioMed Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-15

Primary Completion

2021-01-15

Completion

2021-06-01

Countries

• Romania

Study Locations