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The overall objective of this study is to evaluate the use of diffuse correlation spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with vascular risk factors. Optical cerebral blood flow measurements will be correlated with changes in arterial blood pressure to assess how CBF is maintained in response to changes in ABP, and will be compared to transcranial doppler reference measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thigh Cuff | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD | Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation. | 1.5 hours |
| dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical | Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation. | 1.5 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Linear Relationship Between Rate of Regulation Measured Using TCD and Optics | Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit | 1.5 hours |
Inclusion Criteria:
Exclusion Criteria:
Vascular risk factor subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | We will measure dynamic cerebral autoregulation (dCA) with both transcranial doppler (TCD) and diffuse correlation spectroscopy (DCS) during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD | Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation. | 21 subjects consented, hemodynamic monitoring possible in 18. 1 subject did not tolerate,data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate cerebral blood flow(CBF) was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis | Posted | Number | 95% Confidence Interval | per second | 1.5 hours |
|
Duration of study, which was approximately 6 months.
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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 | Intervention | We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Mullen | University of Pennsylvania | 215-662-3339 | mmullen@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 17, 2016 | Nov 14, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical | Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation. | 21 subjects in the study, but hemodynamic monitoring was only possible in 18. 1 subject did not tolerate, and data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate CBF was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis | Posted | Number | 95% Confidence Interval | per second | 1.5 hours |
|
|
|
| Other Pre-specified | Linear Relationship Between Rate of Regulation Measured Using TCD and Optics | Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit | Posted | Number | slope | 1.5 hours |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |