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临床试验/NCT03596931
NCT03596931已完成不适用

Prior Statin Use and Risk of Heart Failure, Acute Lung Edema and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients

Tarumanagara University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2017年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
Heart Failure

研究概览

简要总结

This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of heart failure, acute lung edema, malignant arrhythmia and death in ACS patients.

详细描述

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9 without a prior history of heart failure, acute lung edema and arrhythmia were included in this study. The inclusion criteria are patients with primary diagnosis of I24.9 and with a complete record of prior medical and treatment history, electrocardiographic findings, cardiac marker results and outcomes. Participants were grouped into 2 groups - statin and non-statin based on prior history of statin use prior to ACS. Diagnosis of ACS was made based on clinical, electrocardiographic and cardiac marker findings found in the medical record.

Data such as age, sex, ethnic, education, prior medical and treatment history, electrocardiographic and cardiac enzyme results as well as outcomes were collected from the patients' medical records. Outcomes of interest were defined as either concomitant heart failure, acute lung edema, malignant arrhythmia, mortality or combinations of them as diagnosed in the medical records. Heart failure is defined based on echocardiographic findings from the medical records. Acute Lung Edema is defined based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation <90%. Whereas malignant arrhythmia is defined as the presence of ventricular tachycardia (VT) or ventricular fibrillation (VF).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Acute Coronary Syndrome
  • Presence of detail on statin prescription history

排除标准

  • History of heart failure, acute lung edema and arrhythmia
  • Unavailability of electrocardiographic findings, cardiac marker results
  • Incomplete records of prior medical and treatment history

研究组 & 干预措施

Statin

History of statin use prior to Acute Coronary Syndrome

干预措施: Statins (Cardiovascular Agents) (Drug)

结局指标

主要结局

Heart Failure

时间窗: Through study completion, an average of 1 year

Based on echocardiographic findings from the medical records

Malignant Arrhythmia

时间窗: Through study completion, an average of 1 year

Presence of ventricular tachycardia (VT) or ventricular fibrillation (VF)

Acute Lung Edema

时间窗: Through study completion, an average of 1 year

Based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation \<90%.

次要结局

未报告次要终点

研究者

发起方
Tarumanagara University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Felicia Sunjaya

Co Principal Investigator

Tarumanagara University

研究点 (1)

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