N/A
N=21
Non-invasive Measurement of Cerebral Dynamic Autoregulation
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02442856 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD — 0.262 per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thigh Cuff (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD |
0.262 | — |
| PRIMARY dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical |
0.278 | — |
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.
Eligibility Criteria
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
- Prisoners
- 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
Data sourced from ClinicalTrials.gov (NCT02442856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.