The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Atrial fibrillation
研究概览
简要总结
The goal of this clinical trial is to answer the research question whether hs Troponin I and NT-proBNP have a role in detecting atrial fibrillation in patients with pacemakers.
Objectives of the study:
- To survey some risk factors for atrial fibrillation in patients with permanent pacemakers.
- To determine the role of hs Troponin I and NT-proBNP in predicting new-onset atrial fibrillation within follow-up time.
- To build a model to predict the prognosis of atrial fibrillation based on the detected subclinical markers related to atrial fibrillation and classic cardiovascular risk factors.
详细描述
Information about age, gender, BMI, medical history, tests to evaluate liver function, kidney function, dyslipidemia, results of echocardiography, ECG, and chest X-ray will be collected from medical records and clinical examination.
The hs troponin I and NT-proBNP tests will be performed before the patient has a pacemaker.
The two tests above will be paid by research team. Patients do not have to pay for these tests.
Atrial fibrillation will be determined through ECG, holter ECG and pacemaker data.
Time to follow up patients in the study: According to the patient's follow-up visits after pacemaker placement: 1 month, 3 months, 6 months, then every 6 months.
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
- 否
入选标准
- •Patient is an adult (≥ 18 years old or older)
- •There is indication for permanent pacemaker placement and patient agreement to permanent pacemaker placement
- •Patient agrees to participate in the study
排除标准
- •Patients had a diagnosis of atrial fibrillation in their past history or atrial fibrillation is discovered at the time of participating in the study
- •Severe patients, at risk of death
- •The patient is indicated for surgery
- •Patients with eGFR ≤ 30 mL/min/1.73m2
- •The patient has a serious infection
结局指标
主要结局
Atrial fibrillation
时间窗: through study completion, an average of 2 year
Symptomatic or asymptomatic AF that is documented by surface ECG. The minimum duration of an ECG tracing of AF required to establish the diagnosis of clinical AF is at least 30 seconds, or entire 12-lead ECG.
次要结局
- Subclinical AF(through study completion, an average of 2 year)
- Atrial high-rate episodes (AHRE)(through study completion, an average of 2 year)
研究者
Linh Ha Khanh Duong
Duong Ha Khanh Linh
University of Medicine and Pharmacy at Ho Chi Minh City