跳至主要内容
临床试验/NCT06670781
NCT06670781招募中不适用

Standardized Goal-Directed Vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 488 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
488
试验地点
2
主要终点
Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver.

研究概览

简要总结

Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial fibrillation, cardiac masses, or atherosclerosis) i.e. cryptogenic stroke, it is recommended to search for a patent foramen ovale (PFO), especially in young patients. It is estimated that cryptogenic stroke accounts for 30% to 40% of ischemic strokes. Transthoracic echocardiography (TTE) with bubble study at rest and during Valsalva maneuver is the reference method for the diagnosis of PFO. The treatment of PFO using a closure device has demonstrated a significant reduction in recurrent stroke events in patients with PFO and cryptogenic stroke. The Valsalva maneuver is currently achieved using self-directed maneuver i.e. patients are instructed to ''bear down'' or ''strain as if attempting to move your bowels.'' These instructions are subjective and depend largely on individuals understanding and effort. A Goal-Directed Valsalva Maneuver using a manometer has been shown to be a more reproducible way to perform the Valsalva achieving more sensitivity in different settings such as hypertrophic cardiomyopathy but its incremental diagnostic value for the detection of PFO has not been yet evaluated.

The aim of the present study is to compare the sensibility and specificity of two methods of Valsalva maneuver for the detection of PFO. We hypothesize that Goal-Directed Valsalva Maneuver will significantly increase the detection rate of PFO compared to Self-Directed Valsalva Maneuver.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

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 referred for a clinically indicated TTE and bubble study

排除标准

  • •Inability to provide informed consent
  • •Inability to insert an IV line
  • •Inability to perform a Self-Directed Valsalva maneuver
  • •Patient wishing to keep his mask on

研究组 & 干预措施

Control - standard of care: Self-Directed Valsalva maneuver

Sham Comparator

The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium.

干预措施: Experimental: Intervention arm: Goal-Directed Valsalva maneuver (Device)

Control - standard of care: Self-Directed Valsalva maneuver

Sham Comparator

The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium.

干预措施: Control - standard of care: Self-Directed Valsalva maneuver (Device)

Intervention arm: Goal-Directed Valsalva maneuver

Active Comparator

For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly.

干预措施: Experimental: Intervention arm: Goal-Directed Valsalva maneuver (Device)

Intervention arm: Goal-Directed Valsalva maneuver

Active Comparator

For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly.

干预措施: Control - standard of care: Self-Directed Valsalva maneuver (Device)

结局指标

主要结局

Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver.

时间窗: From enrollment to the end of echocardiogram (40 minutes from enrollment).

次要结局

  • Rate of large shunt positive bubble study.(From enrollment to the end of echocardiogram (40 minutes from enrollment).)
  • Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver in women and in men.(From enrollment to the end of echocardiogram (40 minutes from enrollment).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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