To Assess Cardiovascular Function
Conditions
Keywords
cardiovascular function, transthoracic echocardiography, global longitudinal strain
Brief summary
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.
Interventions
DEVICEQuantaFlo HD
blood flow at the finger during a forced expiration
Sponsors
Semler Scientific
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Diabetes * Hyperlipidemia
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | From enrollment to the end of treatment is up to 1 week | Accuracy comparing QuantaFlo HD test results to GLS findings |
Countries
United States
Contacts
Primary ContactGena Parker
Outcome results
None listed