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Periodontal Disease, Inflammation and Acute Coronary Syndromes (ATHERODENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395041
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
University of Targu Mures, Romania
University Hospital of Targu Mures, Romania
Information provided by (Responsible Party):
Cardio Med Medical Center

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.

Condition or disease Intervention/treatment
Coronary Stenosis Periodontal Diseases Acute Coronary Syndrome Non-ST Elevation Myocardial Infarction Unstable Angina Acute Myocardial Infarction Atherosclerosis Atheromatous Plaques Diagnostic Test: cardiac imaging tests

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Periodontal Disease, Inflammation and Atherosclerosis Progression in Patients With Acute Coronary Syndromes - the ATHERODENT Study
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
cardiac computed tomography, echocardiography, intravascular ultrasound, optical coherence tomography

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




Primary Outcome Measures :
  1. The rate of major adverse cardiovascular events (MACE rates). [ Time Frame: 24 months ]
    Cardiac death, need for target vessel revascularization (with target vessel defined as the vessel with a vulnerable plaque), or reinfarction.


Secondary Outcome Measures :
  1. The rate of progression of vulnerability degree of non-culprit coronary plaques [ Time Frame: 24 months ]
    Increased severity in vulnerability indexes determined by cardiac imaging tests in the coronary tree

  2. The rate of progression of atheromatous burden and calcium scoring [ Time Frame: 24 months ]
    Increase in atheromatous plaque burden and calcium scoring of the entire coronary tree as determined by Cardio CT

  3. The occurrence of left ventricular remodeling and post-infarction heart failure [ Time Frame: 24 months ]
    Development of ventricular remodeling defined as increase in ventricular diameters with>15% compared to baseline, and of post-infarction heart failure, defined as left ventricular ejection fraction <45% in the posti-infarction period


Biospecimen Retention:   Samples With DNA
Blood samples will be collected for determination of miRNA fractions associated with coronary plaque vulnerability


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395041


Contacts
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Contact: Theodora Benedek, Prof +40722560549 theodora.benedek@gmail.com
Contact: Imre Benedek, Prof +40265211595 imrebenedek@yahoo.com

Locations
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Romania
Cardio Med Recruiting
Târgu-Mureş, Mures, Romania
Contact: Theodora Benedek, Prof    +40722560549    theodora.benedek@gmail.com   
Contact: Imre Benedek, Prof    +40265211595    imrebenedek@yahoo.com   
Sponsors and Collaborators
Cardio Med Medical Center
University of Targu Mures, Romania
University Hospital of Targu Mures, Romania
Investigators
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Principal Investigator: Theodora Benedek, Prof University of Medicine and Pharmacy Tirgu Mures, CardioMed Medical Center
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Responsible Party: Cardio Med Medical Center
ClinicalTrials.gov Identifier: NCT03395041    
Other Study ID Numbers: CM0117-ATD
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be made available to other researchers from the same group and to other collaborating groups and can be used for further statistical sub-analysis
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will become available immediately after completion of the enrolment and will remain available for at least 5 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardio Med Medical Center:
vulnerable plaque, CT imaging, oral bacteria, inflammation
Additional relevant MeSH terms:
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Periodontal Diseases
Myocardial Infarction
Acute Coronary Syndrome
Atherosclerosis
Angina, Unstable
Coronary Stenosis
Non-ST Elevated Myocardial Infarction
Syndrome
Inflammation
Infarction
Plaque, Atherosclerotic
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Mouth Diseases
Stomatognathic Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Coronary Disease
Pathological Conditions, Anatomical