跳至主要内容
临床试验/CTRI/2024/03/064822
CTRI/2024/03/064822进行中(未招募)不适用

Assessment of coexistence of autonomic dysfunction in patients with syncope.

Kasturba Medical College, Manipal Academy of Higher Education, Manipal1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年4月2日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
34
试验地点
1
主要终点
LVOT VTI

研究概览

简要总结

This study will be conducted after Institutional Research Committee and Institutional Ethics Committee approval and CTRI registration. Participants satisfying the inclusion criteria will be carefully chosen for the study. Participants with syncope referral for Head Up Tilt Table Test will be undergoing electrocardiogram (ECG) and echocardiography screening test for cardiac evaluation. Details pertaining to the need of the test will be explained to the participant and written informed consent will be taken for the same. Participants with syncope and no known cardiovascular disease will undergo Head Up Tilt Table Test and autonomic function testing. Autonomic function test will be performed using heart rate variability as per standard guidelines by 1996 Taskforce statement using time and frequency domain measures and the Italian protocol will be followed for the HUTT test. Various echocardiographic parameters will be recorded and stored at every stage of the procedure of head up tilt table test. 2D echocardiography will be used for obtaining standard views like (PLAX, A4C, A5C) and PW Doppler for LVOT VTI as a part of routine evaluation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • participants with syncope above the age of 18 years.

排除标准

  • Participants who present with postural orthostatic tachycardia syndrome
  • Participants with cardiovascular diseases such as: -Arrhythmias. -Ischemic heart disease (IHD). -Cardiomyopathies. -Valvular heart diseases (VHD). -Congenital heart diseases (CHD).
  • Pericarditis -Pacemaker implantation. -Cardiac tumors or thrombus.
  • Pregnant women
  • participants with poor echo window.

结局指标

主要结局

LVOT VTI

时间窗: All outcomes at baseline, syncope and recovery stages.

Cardiac Output

时间窗: All outcomes at baseline, syncope and recovery stages.

Cardiac Index

时间窗: All outcomes at baseline, syncope and recovery stages.

Stroke volume index

时间窗: All outcomes at baseline, syncope and recovery stages.

Left ventricular stroke work index

时间窗: All outcomes at baseline, syncope and recovery stages.

Myocardial performance index

时间窗: All outcomes at baseline, syncope and recovery stages.

次要结局

未报告次要终点

研究者

发起方
Kasturba Medical College, Manipal Academy of Higher Education, Manipal
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shivani Rao

Manipal College of Health Professions

研究点 (1)

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