An observational study in Coronary Stenosis, Periodontal Diseases and Acute Coronary Syndrome, sponsored by Cardio Med Medical Center. Completed at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Cardio Med Medical Center · Observational
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.
ATHERODENT is a case-controlled observational clinical study, conducted in two clinical sites: University of Medicine and Pharmacy Tirgu Mures, Romania, and Cardio Med Medical Center - Laboratory of Advanced Research in Multimodality Imaging.
The primary objective of ATHERODENT is to assess the interrelation between PD, inflammation and atherosclerosis progression in patients who suffered an ACS and have concomitant PD vs those with ACS and no PD, using (1) invasive and non-invasive imaging techniques for characterization of vulnerable coronary plaques; (2) full characterization of PD; and (3) complex assessment of systemic vulnerability based on systemic inflammation-related biomarkers.
The secondary objectives of ATHERODENT are:
Baseline will be considered as the moment of the index event and related hospitalization. The index event will be considered the ACS and patients will be randomized in the study at maximum 7 days post ACS. The follow-up visits will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization.
The following procedures will be performed at baseline:
Follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization, including assessment of clinical data, echocardiography and registration of MACE and adverse events.
In addition, complex imaging assessment using Angio CT will be performed at 2 years to assess atherosclerosis progression.
326 studies on the registry are indexed under Coronary Stenosis; 57 are open to participants now.
This study's enrollment of 149 is below the median of 200 across 125 observational studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →Cardio Med Medical Center is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with acute coronary syndromes (unstable angina or NSTEMI), who undergo invasive coronary angiography +/- revascularization (according to local protocols).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: 24 months
The rate of progression of vulnerability degree of non-culprit coronary plaques
Increased severity in vulnerability indexes determined by cardiac imaging tests in the coronary tree
Time frame: 24 months
The rate of progression of atheromatous burden and calcium scoring
Increase in atheromatous plaque burden and calcium scoring of the entire coronary tree as determined by Cardio CT
Time frame: 24 months
The occurrence of left ventricular remodeling and post-infarction heart failure
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
Time frame: 24 months
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will become available immediately after completion of the enrolment and will remain available for at least 5 years.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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