Epicardial Fat in Cardiovascular Diseases
追踪信息 | |||
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首次提交日期 ICMJE | September 30, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | September 1, 2018 | ||
预计主要完成日期 | December 31, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
EAT pro-arrhythmogenic genes[ Time Frame: 24 hours ] Differences in pro-arrhythmogenic transcriptome between peri-atrial EAT, peri coronary EAT and SAT in patients with and without AF |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Epicardial Fat in Cardiovascular Diseases | ||
正式标题 ICMJE | Epicardial Fat as Brown and Arrhythmogenic Fat in Coronary Artery Disease | ||
简要概况 | Epicardial adipose tissue (EAT) is the visceral fat depot of the heart. EAT transcriptome is unique when compared to subcutaneous fat. EAT is a highly inflammatory tissue enriched with genes involved in inflammation, endothelial function, immune signaling and thermoregulation. EAT has been correlated with coronary artery disease (CAD) and atrial fibrillation (AF), although the mechanisms of the interplay of EAT with these two major cardiovascular diseases have not been fully understood. Whether EAT may act as brown fat and whether this may be affected by the presence of CAD is currently unknown. Whether the postulated thermoregulatory function of the EAT is correlated to the presence and severity of CAD is unknown EAT is though to play a role in the development and recurrence of AF. Recent studies showed that EAT has a unique transcriptome with genes encoding for pro-arrhythmogenic proteins. EAT is located in different areas of the heart. Whether regional EAT depots may have different genetic profile and functions is unknown. Whether peri-atrial EAT may have unique effects on cardiac muscle activity distinct from other EAT sub-depots is unknown. Peri left atrial EAT and pericoronary EAT will be collected from patients who are undergoing elective cardiac surgery as standard care. EAT transcriptome will be analysed with RNA- sequencing analysis (RNA-seq) and quantitative real time polymerase chain reaction (qRT-PCR) . Immunofluorescence and immunoblot will be also performed on fat samples. |
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详细说明 | |||
研究类型 ICMJE | Observational | ||
研究阶段 | |||
研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
60 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | June 30, 2020 | ||
预计主要完成日期 | December 31, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Patients with paroxysmal or persistent AF (Group 1). Paroxysmal AF is defined per the guidelines as recurrent AF (2 episodes) that terminates spontaneously within 7 days. Persistent AF is defined per the guidelines as continuous AF that is sustained beyond 7 days (or AF in which a decision is made to cardiovert the patient after ≥48 hours of AF, but prior to 7 days). - Patients with clinically and angiographically established CAD who require CABG, as part of the standard medical care (Group 1 and 2); - age > 18 years old; - absence of signs and history of CAD in the control group. The absence or presence of CAD will be determined by the cardiologists and cardiac surgeons based on clinical history, pre-operative coronary angiography and other routine tests (All groups). Exclusion Criteria: - Acute or chronic infective diseases; - cancer or chemotherapy; - history of pulmonary, (pulmonary embolism, etc) renal or liver diseases, - hypo- and hyperthyroidism, - drug abuse; - patients with a life expectancy <1 year - Pregnant or breast-feeding women | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Gianluca Iacobellis,University of Miami | ||
研究赞助商 ICMJE | University of Miami | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | University of Miami | ||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |