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Clinical Trials/NCT02442856
NCT02442856CompletedNot Applicable

Non-invasive Measurement of Cerebral Dynamic Autoregulation

University of Pennsylvania2 sites in 1 country21 target enrollmentStarted: June 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
2
Primary Endpoint
dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age greater than or equal to 50 years
  • Positive history of at least one of the following vascular disk factors: hypertension, diabetes, hyperlipidemia, coronary artery disease, atrial fibrillation, prior myocardial infarct, transient ischemic attack, or history of smoking

Exclusion Criteria

  • Vascular risk factor subjects:
  • Pregnant women
  • Prior neurosurgical procedure or traumatic brain injury, including hemicraniectomy or other skull defect
  • Prior history of ischemic or hemorrhagic stroke
  • Prior lower extremity amputation
  • Peripheral vascular disease

Outcomes

Primary Outcomes

dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical

Time Frame: 1.5 hours

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.

dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD

Time Frame: 1.5 hours

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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