Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Heart failure detection
研究概览
简要总结
The study will test the ability a novel wearable sensor based on a smartphone app (Precordior CardioSignal app) in combination with a sensor device (Suunto Movesense sensor) to non-invasively measure cardiac motion and function.
详细描述
Heart Failure (HF) is a syndrome where the heart is unable to pump or fill adequately to meet the circulatory needs of the body. The main purpose of this study is to test the ability a novel wearable sensor based on a smartphone app (Precordior CardioSignal app) in combination with a sensor device (Suunto Movesense sensor) to non-invasively measure cardiac motion and function. The phone and sensor are positioned on the chest and echocardiography is used as a gold standard to assess cardiac mechanics including myocardial strain, cardiac torsion, diastolic filling characteristics, hemodynamics including pressure estimates and stroke volume.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Able to consent in English and follow study instructions
- •Patients hospitalized or being seen in clinic with heart failure with a diagnosis of HFpEF, HFrEF or PH, as corresponding to each target patient group
- •Control patients may include patients that are hospitalized without heart failure, and cardiology patients without heart failure who are seen in outpatient cardiology, who may have suspected CAD and are scheduled for CCTA.
排除标准
- •Severe cardiac valvular heart disease
- •Previous prosthetic cardiac valve
- •Pericardial disease including constrictive pericarditis or moderate or large pericardial effusion
- •Mechanical circulatory support (including ECMO, LVADs etc).
- •Heart and/or lung transplant recipients
- •Major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment
- •Patients with pacemaker that has over 1% of beats paced
- •Pectus excavatum (severe)
- •Pregnant women
- •On Dialysis
- •Exclude at the clinical discretion of the Principal Investigators
- •Not possible to acquire echocardiography with sufficient quality
结局指标
主要结局
Heart failure detection
时间窗: Baseline to Day 2
Test the ability of the Precordior sensor to detect heart failure with reduced ejection fraction, heart failure with preserved ejection fraction and pulmonary hypertension compared to control participants. An additional comparison will be made to individuals without signs, diagnosed, or suspected HF who will be undergoing CCTA due to suspected CAD.
次要结局
- Detection of differences in myocardial mechanics between admission and discharge(up to 2 weeks (during admission) and 2 to 14 weeks (during follow-up visit).)
研究者
Francois Haddad
Clinical Professor Medicine - Med/Cardiovascular Medicine
Stanford University