Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms. (CAC-TRAIT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Coronary artery calcium score
研究概览
简要总结
The goal of this observational study is to determine the diagnostic accuracy of peripheral whole blood transcriptomes analyzed by an artificial intelligence algorithm to detect the presence and extent of coronary calcification in individuals without a history of known cardiovascular disease.
The main question it aims to answer is:
- Will the proposed method predict the presence and extent of coronary artery calcification from the peripheral whole-blood transcriptomes?
详细描述
This study will be a prospective observational single-site study. A convenience sample will be carried out to include 800 patients who attend the Clinic, to undergo a cardiac CT without contrast (coronary calcium score), either for a medical indication or volunteers for an assessment of cardiovascular risk. The study will have a baseline stage in which a clinical evaluation will be performed, blood samples will be drawn for transcriptome analysis and laboratory analysis. Then, a DNA sample obtained by swabbing the buccal mucosa will be taken. Subsequently, a non-contrast gated cardiac CT will be performed to assess the presence and extent of coronary calcification and other outcomes of interest. At the end of patient enrollment, biological samples will be sequenced for in silico evaluation of the results. Finally, a 5-year clinical (telephone) follow-up will be carried out to collect data on the incidence of fatal and non-fatal cardiovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 30 and 75 years attending the institution for a non-contrast cardiac CT scan (coronary calcium score) either by medical indication or voluntary for cardiovascular risk assessment.
- •Signature of the informed consent form
排除标准
- •Previously known chronic renal or hepatic insufficiency.
- •Active chronic lung disease, defined as exacerbated asthma, exacerbated chronic obstructive pulmonary disease (COPD), or pulmonary fibrosis.
- •Active and/or previous cardiovascular disease, defined as previous acute myocardial infarction, stable or unstable angina, cerebrovascular accident, history of vascular interventions (coronary or another territory), heart failure, severe cardiomyopathies, or valvulopathies.
- •Uncontrolled hyper or hypothyroidism.
- •Suprarenal insufficiency.
- •Previous surgeries in the last 3 months.
- •Severe trauma in the last 6 months, defined as one that involved bone fractures and/or surgical interventions.
- •Known active cancer disease or under treatment (acute or preventive), or history of cancer disease without criteria for a cure.
- •Known autoimmune disease active or in treatment.
- •Ongoing pregnancy, postpartum period of fewer than 12 months, or breastfeeding.
- •Other serious illnesses with an estimated life expectancy of fewer than 12 months (according to the investigators).
- •Temperature greater than 37.5°C recorded by a thermometer or any acute infection caused by viruses or bacteria confirmed by a health professional in the previous 30 days.
- •Pathologies under immunosuppressive treatment
结局指标
主要结局
Coronary artery calcium score
时间窗: At baseline (cross-sectional assessment)
Coronary artery calcium (CAC) score (Agatston units) stratified with increasing risk according to the Society of Cardiovascular Computed Tomography Guidelines as CAC=0; CAC 1-99; CAC 100-299; and CAC≥300.
次要结局
- Epicardial adipose tissue (density)(At baseline (cross-sectional assessment))
- Left ventricular hypertrophy(At baseline (cross-sectional assessment))
- cerebrovascular event(year 1 through 5)
- Coronary artery calcium score(At baseline (cross-sectional assessment))
- Epicardial adipose tissue (volume)(At baseline (cross-sectional assessment))
- Fatty liver(At baseline (cross-sectional assessment))
- Cancer(year 1 through 5)
- Aortic valve calcium(At baseline (cross-sectional assessment))
- Thoracic aorta calcium(At baseline (cross-sectional assessment))
- High-sensitive C reactive protein (CRP)(At baseline (cross-sectional assessment))
- Repolarization abnormalities(At baseline (cross-sectional assessment))
- Vascular revascularization(year 1 through 5)
- Neutrophil to lymphocyte ratio(At baseline (cross-sectional assessment))
- Intraventricular conduction abnormalities(At baseline (cross-sectional assessment))
- Percent electron density relative to water (%EDW)(At baseline (cross-sectional assessment))
- Death(year 1 through 5)
- Coronary artery calcium score (number of segments)(At baseline (cross-sectional assessment))
- Acute ischemic syndrome(year 1 through 5)
- Heart failure(year 1 through 5)
研究者
Santiago Gabriel Miriuka
Co-Founder & CEO
MultiplAI Health Limited