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临床试验/NCT03795883
NCT03795883已完成不适用

The Thrombotic Potential (Thrombin Generation) of Left Atrium and Other Heart Chambers in Atrial Fibrillation Patients Compared to Patients Without Atrial Fibrillation.

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)

研究概览

简要总结

The investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation and compared to patients without atrial fibrillation admitted for left sided supra ventricular tachycardia or mitral clip. Thrombin generation parameters will be assessed by the calibrated automated thrombogram.

详细描述

Atrial fibrillation is the most common arrhythmia, there is a strong correlation between atrial fibrillation and embolic stroke. In order to lower the risk for embolic stroke anticoagulation is recommended for patients with CHADS-VASC score equal or above 2. The mechanism for thrombus formation in the left atrium is thought to be caused by various factors 1. blood stasis due to the loss of atrial kick 2. endothelial dysfunction 3. blood hemostatic alteration leading to procoagulant state.

Previous studies demonstrated increased thrombin generation in the left atrium in patients with atrial fibrillation, when compared to other heart chambers and when compared to control group in patients with structurally normal heart.

In recent years calibrated automated thrombogram (CAT) is considered a good indicator for total thrombotic activity in hypercoagulable states.

In the current study the investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation without changing the course of the procedure. Thrombin generation parameters will be assessed by the calibrated automated thrombogram. A control group composed of 50 patients admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure without the presence of atrial fibrillation.

In addition demographic data,CHADS-VASC score, atrial fibrillation burden, echocardiographic and cardiac CT parameters will be collected.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18
  • Pulmonary vein ablation, SVT ablation or mitral clip.
  • Informed consent

排除标准

  • Left atrial thrombus
  • Pregnancy
  • Active malignancy
  • Thrombophilia
  • Anticoagulants 24 hours before procedure
  • Active infectious disease
  • Chronic kidney disease (eGFR<30)

结局指标

主要结局

Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)

时间窗: 1 Day

Peak height nM

ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)

时间窗: 1 Day

ETP (endogenous thrombotic potential) nM\*min

Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)

时间窗: 1 Day

Lag time in minutes

Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)

时间窗: 1 Day

Time to peak in minutes

次要结局

  • The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)(1 Days)
  • The 1 year incidence of thromboembolic events(1 Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adi Elias MD

Resident Physician at Cardiology Department, Principal Investigator

Rambam Health Care Campus

研究点 (1)

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