NCT03395041: ATHERODENT

Periodontal Disease, Inflammation and Acute Coronary Syndromes

Completed Last updated 2 August 2022

What this trial tests

trial testing cardiac imaging tests in Coronary Stenosis in 149 participants. Completed in 1 June 2021.

Timeline

15 May 2018

Primary endpoint
15 January 2021

1 June 2021

Quick facts

Lead sponsor	Cardio Med Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	149
Start date	15 May 2018
Primary completion	15 January 2021
Estimated completion	1 June 2021
Sites	1 location across Romania

Drugs / interventions tested

• cardiac imaging tests

Conditions studied

• Coronary Stenosis — all drugs for Coronary Stenosis →
• Periodontal Diseases — all drugs for Periodontal Diseases →
• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Non-ST Elevation Myocardial Infarction — all drugs for Non-ST Elevation Myocardial Infarction →

Sponsor

Cardio Med Medical Center

Who can join

18 and older, any sex, with Coronary Stenosis or Periodontal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Periodontal Disease Is Associated with Increased Vulnerability of Coronary Atheromatous Plaques in Patients Undergoing Coronary Computed Tomography Angiography-Results from the Atherodent Study.
   Rodean IP, Lazăr L, Halațiu VB, Biriș C, et al · · 2021 · cited 11× · PMID 33800969 · DOI 10.3390/jcm10061290
2. Association Between Periodontal Pathogens and Inflammation in Patients with Acute Coronary Syndromes.
   Rodean IP, Halațiu VB, Popa TM, Blîndu E, et al · · 2025 · cited 1× · PMID 40362598 · DOI 10.3390/ijms26094360