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Measuring Cardiovascular Performance Using Common Methods in subjects.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects enrolled | The feasibility of conducting all three tests, echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), on all subjects met the enrollment criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Diagnostic Test | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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45 Years and older Female and Male
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| Name | Affiliation | Role |
|---|---|---|
| Jim Kermode | Semler Scientific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Middle Georgia Heart and Vascular Center | Macon | Georgia | 31210 | United States | ||
| Integrated Cardiology Group, LLC, d/b/a Bryan Heart |
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The Protocol was amended to include measurement of Brain Natriuretic Peptide (BNP) later in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Enrolled. | 1 day for the collection of the test results of the 657 participants was performed for Echocardiography and Volume plethysmography tests. And 1 day for the collection of Brain Natriuretic peptide (BNP) tests results of 236 participants was conducted. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Protocol was amended to include measurement BNP participants. 657 participants had Echo and VP, while 236 of the same 657 group of participants also had BNP measurement.
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| ID | Title | Description |
|---|---|---|
| BG000 | Measuring Cardiovascular Performance and Blood Flow. | Echocardiography (Echo), Brain Natriuretic Peptide (BNP), and volume plethysmography (VP) were performed in human subjects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The Protocol was amended to include 236 participants for the measurement of Brain Natriuretic Peptide (BNP). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Count of Participants | Participants | Baseline |
|
Baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Measuring Cardiovascular Performance and Blood Flow. | The feasibility of conducting all three tests on all subjects met the enrollment criteria. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gena Parker | Semler Scientific | 669-230-2729 | gparker@semlerscientific.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2021 | Jun 28, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2022 | Jan 23, 2023 | SAP_002.pdf |
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| Lincoln |
| Nebraska |
| 68506 |
| United States |
| JF Southwest Heart Clinic, P.A. | Houston | Texas | 77072 | United States |
| Southwest Clinical Trials | Houston | Texas | 77081 | United States |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Brain Natriuretic Peptide (BNP) | 236 subjects of the 657 subjects could safely do the Brain Natriuretic Peptide (BNP) tests. The quality of the test results was not assessed in this study. |
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| 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). | 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. | Posted | Count of Participants | Participants | Baseline |
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|
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| 0 |
| 657 |
| 0 |
| 657 |
| 0 |
| 657 |
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| Not recorded |
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