NCT07219693招募中不适用
QuantaFlo HD Clinical Validation Study
Semler Scientific1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年8月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration ("FE"). The study examines whether Echo-measured GLS values greater than -16% correlate with abnormal responses during FE as measured by QuantaFlo HD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adult (≥ age 22) subjects with a minimum of 1 of the following:
- •A history of Cardiovascular Diseasei or PAD
- •Recorded history of at least two of the following
- •Hypertension
- •Hyperlipidemia
排除标准
- •Unable to safely perform a forced expiration, or unable to obtain a technically adequate FE test result
- •Subjects with a pacemaker or ICD with pacemaker function
- •Terminal advanced illness
- •Recent cardiothoracic surgery (within 12 months)
- •Retinal eye disease with anticoagulants
- •History of eye surgery, within 90 days
- •Uncontrolled hypertension >180 mmHg systolic pressure or >100 mmHg diastolic pressure
- •Subjects with severe tremors
结局指标
主要结局
Sensitivity and Specificity
时间窗: From enrollment to the end of treatment is up to 1 week
Evaluate the sensitivity and specificity of QuantaFlo HD test results to GLS findings.
次要结局
- Accuracy(From enrollment to the end of treatment is up to 1 week)
研究者
研究点 (1)
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