A Retrospective Cohort Study on the Burden of New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction at Shanghai Tenth People's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,399
- 试验地点
- 1
- 主要终点
- Major adverse cardiac event (MACE)
研究概览
简要总结
To characterize and estimate the incidence rate of new-onset atrial fibrillation (NOAF) in patients with acute myocardial infarction (MI). To explore the prognostic influences of NOAF on MI patients' clinical outcomes. To further investigate the impact of NOAF associated characteristics on patients' clinical outcomes eithier during hospitalization or follow-up period.
详细描述
In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital between February 2014 and March 2018.
All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, acute and dischage medications, and clinical outcomes will be collected. All patients admitt to our CCU department will receive CEM immediately after admission and continue until discharge. Heart thythm status and those characteristics assoicated with NOAF will be reviewed by several independent physicians and recorded in a centralized electronic database.
Several post-MI NOAF assoicated characteristics and definitions are displayed as follows:
- Total CEM duration is defined as the period during which the monitor was started after admission and turned off before discharge.
- AF maintained duration is defined as the period during which an AF episode presented and terminated.
- Total AF duration is calculated by summing all AF episodes' maintained durations descripted above.
- AF burden was calculated by dividing the total AF duration by the total CEM duration.
- NOAF pattern included paroxysmal NOAF, persistent NOAF, transient NOAF, and persisting NOAF, definitions are demonstrated as follows:
- Paroxysmal NOAF is defined as more than 1 episodes of AF occur during hospitalization irrespective of the discharge rhythm status or only 1 episode of AF is observed during hospitalization and maintain sinus rhythm at discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 hospitalized for acute MI between February 2014 and March 2018 in the CCU department of Shanghai Tenth People's Hospital;
- •Adult patients (>18 years old).
排除标准
- •Patients with a medical history of pre-existing AF;
- •Patietns with a medical histroy of Rheumatic valvular disease;
- •Patietns with a medical histroy of sick sinus syndrome;
- •Patients undergoing emergent coronary artery bypass surgery;
- •Patients' medical records with serious deficiencies and critical information (e.g. demographic data, laboratory testings, etc.) cannot be retrieved;
- •Patients who refused to receive electronic monitoring during hospitalization and the data of cardiac rhythm cannot be obtained;
- •Premature discharge due to nonmedical reasons such as nonpayment, failure to comply with program rules, conflicting with treatment staff, etc.
结局指标
主要结局
Major adverse cardiac event (MACE)
时间窗: From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years
Cardiovascular death, recurrent myocardial infarction, rehospitalization for heart failure or stroke
次要结局
- Cardiovascular death(From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years)
- Stroke(From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years)
- Ischemic stroke at 30 days(30 days)
- All-cause death(From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years)
- Recurrent myocardial infarction(From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years)
- Rehospitalization for heart failure(From the time of admission to coronary care unit until occurrence of an outcome of interest, death, loss to follow up or April 10, 2019, maximum up to 5 years)
- In-hospital cardiogenic shock(From the time of admission to coronary care unit until discharge)
- New congestive heart failure at 30 days(30 days)
- In-hospital MACE(30 days)
- Nonfatal re-infarction at 30 days(30 days)
- In-hospital sustained ventricular tachycardia/ventricular fibrillation(From the time of admission to coronary care unit until discharge)
研究者
Ya-Wei Xu
Chief Physician
Shanghai 10th People's Hospital