D001775, D012039
Conditions
Brief summary
Measuring Cardiovascular Performance Using Common Methods in subjects.
Detailed description
This study will conduct measurements of cardiovascular performance by echocardiography (Echo), Brain Natriuretic Peptide (BNP) blood serum levels and blood flow by volume plethysmography (VP) in subjects who meet the AHA/ACC criteria for screening for peripheral arterial disease (PAD).
Interventions
DIAGNOSTIC_TESTNo intervention
No intervention
Sponsors
Semler Scientific
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), ≤75% (36) Male, ≥25% (12) Female * At least 50 Patients from NYHA Class 2 (symptomatic), ≤75% (36) Male, ≥25% (12) Female
Exclusion criteria
* Subjects on mechanical ventilation. * Subjects who require decisions by a medical power of attorney. * Subjects unable to safely perform forced expiration. * Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Performing Echo, BNP, and VP on Human Subjects. | Baseline | The feasibility of performing three common tests, Echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), in the same subject was assessed. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test (plethysmography (VP) and Echocardiography (Echo)). Each of the 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP). |
Countries
United States
Participant flow
Pre-assignment details
The Protocol was amended to include measurement of Brain Natriuretic Peptide (BNP) later in the study.
Participants by arm
| Arm | Count |
|---|---|
| Measuring Cardiovascular Performance and Blood Flow. Echocardiography (Echo), Brain Natriuretic Peptide (BNP), and volume plethysmography (VP) were performed in human subjects. | 657 |
| Total | 657 |
Baseline characteristics
| Characteristic | Measuring Cardiovascular Performance and Blood Flow. | — |
|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.76 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 657 Participants | — |
| Sex/Gender, Customized Female | 276 Participants | — |
| Sex/Gender, Customized Male | 379 Participants | — |
| Sex/Gender, Customized Not Recorded | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 657 |
| other Total, other adverse events | 0 / 657 |
| serious Total, serious adverse events | 0 / 657 |
Outcome results
Primary
Feasibility of Performing Echo, BNP, and VP on Human Subjects.
The feasibility of performing three common tests, Echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), in the same subject was assessed. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test (plethysmography (VP) and Echocardiography (Echo)). Each of the 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).
Time frame: Baseline
Population: All subjects could safely do the Echo and VP tests, and after the protocol was amended, 100% of subjects could safely do the BNP as well. The quality of the test results was not assessed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Echo, Volume Plethysmography | Feasibility of Performing Echo, BNP, and VP on Human Subjects. | 657 Participants |
| Brain Natriuretic Peptide (BNP) | Feasibility of Performing Echo, BNP, and VP on Human Subjects. | 236 Participants |
Post Hoc
Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS).
An Ultrasound scan and a measurement of natriuretic peptides (BNP) in the blood were used to compute Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS) to determine a diagnosis of Heart Failure. Theses results were compared to the results of QuantaFlo, which automatically grades the measurement results as typical for heart failure or normal. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test. A subset of 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).
Time frame: Baseline
Population: All subjects (657), adults male and female, safely had the Echo and VP tests, and after the protocol was amended, to include the Brain Natriuretic Peptide (BNP) test results of a subset of 236 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Echo, Volume Plethysmography | Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). | Male | 379 Participants |
| Echo, Volume Plethysmography | Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). | Female | 276 Participants |
| Echo, Volume Plethysmography | Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). | Not recorded | 2 Participants |
| Brain Natriuretic Peptide (BNP) | Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). | Male | 177 Participants |
| Brain Natriuretic Peptide (BNP) | Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). | Female | 59 Participants |
| Brain Natriuretic Peptide (BNP) | Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). | Not recorded | 0 Participants |