跳至主要内容
临床试验/CTRI/2025/04/085985
CTRI/2025/04/085985尚未招募不适用

Comparison of LA function in cryptogenic stroke patients and healthy controls using 3D Echocardiography: A case and control study

Manipal academy of higher education1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
88
试验地点
1
主要终点
To compare LA strain and volume by 3D echocardiography in cryptogenic stroke patients and age-gender matched normal individuals

研究概览

简要总结

Aim: To compare Left atrial (LA) function in cryptogenic stroke patients and healthy controls using 3D echocardiography.

Justification for study:   Previous studies didn’t include three LA strain parameters and LA volume in the assessment of LA function by more accurate 3D echocardiography in cryptogenic stroke patients. Identifying subclinical LA dysfunction by LA strain parameters in 3D echocardiography, provides more insights into underlying mechanisms in cryptogenic stroke patients.

This study helps to understand the LA dynamics in Cryptogenic stroke patients and in risk stratification of Cryptogenic stroke patients.

Detailed description of procedure / processes:

After IRC (Institutional research committee), IEC (Institutional ethics committee) approval and CTRI registration (Clinical Trials Registry- India). Cryptogenic stroke patients and age and gender match normal individuals referred for echocardiography will be taken for the study. Test details are explained to the subject and consent will be taken and 12 Lead ECG will be obtained. Echocardiographic parameters will be recorded and analyzed in offline LA strain. Needed 2D echocardiography standard views (A4C, A2C) will be scanned and stored by an experienced cardiac sonographer. Mitral PW doppler and tissue doppler velocities at septal and lateral walls will be recorded. And Conventional echo parameters like LA volume, LA dimension, LA EF, and LA strain will be obtained.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Cases: Cryptogenic stroke patients with no history of more than Mild VHD, CAD, CHD Age less than 50years
  • Controlled individuals: Normotensive individuals, age and gender matched group who are referred for echocardiography.

排除标准

  • Arrhythmias (Any history of AF or atrial flutter) – diagnosed by ECG or 3-day Holter monitoring
  • Pregnancy
  • Valvular Heart Disease (VHD)
  • Coronary Artery Disease (CAD)
  • Congenital Heart Disease (CHD)
  • Known or suspected cardiomyopathy.

结局指标

主要结局

To compare LA strain and volume by 3D echocardiography in cryptogenic stroke patients and age-gender matched normal individuals

时间窗: Baseline

次要结局

  • Comparison of LA appendage morphology between two groups(Baseline)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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