Periodontal Disease, Inflammation and Atherosclerosis Progression in Patients With Acute Coronary Syndromes - the ATHERODENT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- The rate of major adverse cardiovascular events (MACE rates).
研究概览
简要总结
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.
详细描述
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:
- to study the correlation between PD and coronary plaque vulnerability
- to assess the correlation between PD and severity of coronary atherosclerosis
- to assess the presence and burden of oral bacteria in coronary atheromatous plaques collected during atherectomy and their relation with plaque vulnerability and evolution following an ACS (in the atherectomy sub-study).
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The rate of major adverse cardiovascular events (MACE rates).
时间窗: 24 months
Cardiac death, need for target vessel revascularization (with target vessel defined as the vessel with a vulnerable plaque), or reinfarction.
次要结局
- The rate of progression of atheromatous burden and calcium scoring(24 months)
- The rate of progression of vulnerability degree of non-culprit coronary plaques(24 months)
- The occurrence of left ventricular remodeling and post-infarction heart failure(24 months)