Periodontal Disease, Inflammation and Acute Coronary Syndromes

NCT03395041 | Completed DMC

• 1 other identifier: CM0117-ATD
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vulnerable plaque, CT imaging, oral bacteria, inflammation

Outcome Measures

Primary Outcomes (1)

• The rate of major adverse cardiovascular events (MACE rates).

  Cardiac death, need for target vessel revascularization (with target vessel defined as the vessel with a vulnerable plaque), or reinfarction.

  24 months

Secondary Outcomes (3)

• The rate of progression of vulnerability degree of non-culprit coronary plaques

  24 months

• The rate of progression of atheromatous burden and calcium scoring

  24 months

• The occurrence of left ventricular remodeling and post-infarction heart failure

  24 months

Study Arms (2)

ATD - SG 01

Patients with acute coronary syndrome in whom dental examination performed in the first 7 days after the index event revealed the presence of periodontal disease. They will undergo complex cardiac imaging tests to assess plaque vulnerability and severity of coronary artery disease.

Diagnostic Test: cardiac imaging tests

ATD - SG 02

Patients with acute coronary syndrome in whom dental examination performed in the first 7 days after the index event did not reveal the presence of periodontal disease. They will undergo complex cardiac imaging tests to assess plaque vulnerability and severity of coronary artery disease.

Diagnostic Test: cardiac imaging tests

Interventions

cardiac imaging tests DIAGNOSTIC_TEST

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

ATD - SG 01; ATD - SG 02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute coronary syndromes (unstable angina or NSTEMI), who undergo invasive coronary angiography +/- revascularization (according to local protocols).

You may qualify if:

• Patients aged at least 18 years;
• Patients who have signed the written informed consent;
• Patients with ACS (unstable angina or non-ST segment elevation myocardial infarction) occurring with maximum 7 days prior to enrollment

You may not qualify if:

• Patient's refusal to participate in the study;
• Sensitivity to the contrast substance;
• Women of reproductive age who do not use contraceptive methods;
• Pregnant women;
• Any malignancy within the last 5 years;
• Any disease or comorbidity that can reduce life expectancy to less than 2 years;
• Acute or chronic renal failure;
• Non-compliant patients who, in the opinion of the investigators, will not present to follow-up.

Sponsors & Collaborators

• Cardio Med Medical Center: lead
• University of Targu Mures, Romania: collaborator
• University Hospital of Targu Mures, Romania: collaborator

Study Sites (1)

Cardio Med

Târgu Mureş, Mureș County, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for determination of miRNA fractions associated with coronary plaque vulnerability

MeSH Terms

Conditions

Coronary Stenosis; Periodontal Diseases; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Angina, Unstable; Atherosclerosis; Plaque, Atherosclerotic; Inflammation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mouth Diseases; Stomatognathic Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical

Study Officials

• Theodora Benedek, Prof

  University of Medicine and Pharmacy Tirgu Mures, CardioMed Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 10, 2018
• Study Start: May 15, 2018
• Primary Completion: January 15, 2021
• Study Completion: June 1, 2021
• Last Updated: August 2, 2022

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available immediately after completion of the enrolment and will remain available for at least 5 years.

Locations

RO (1)