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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL071379 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Pixel Velocity, Inc. / Epsilon Imaging | INDUSTRY |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study. | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography system Ultra DCI Model 5000 | Device | Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function. |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Circumferential Strain Rate During Isovolumic Relaxation | Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function. | Assessed from echo obtained at time of enrollment |
| Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler | E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function. | Assessed from echo obtained at time of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore J Kolias, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Cardiovascular Center | Ann Arbor | Michigan | 48109-5853 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Diastolic Circumferential Strain Rate During Isovolumic Relaxation | Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function. | Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects. | Posted | Mean | Standard Deviation | 1/sec | Assessed from echo obtained at time of enrollment |
|
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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 | Single Arm Study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theodore J. Kolias, MD | University of Michigan | (734) 615-4907 | tkolias@umich.edu |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Echocardiography machine GE Vivid E9 | Device | Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function. |
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| Diastolic function assessment | Device | Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Grade 1 Diastolic Dysfunction | These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0). |
| OG002 | Grade 2 Diastolic Dysfunction | These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg). |
|
|
| Primary | Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler | E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function. | Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects. | Posted | Mean | Standard Deviation | cm/sec | Assessed from echo obtained at time of enrollment |
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| 0 |
| 50 |
| 0 |
| 50 |
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