A Prospective Evaluation of Clinical Outcomes in Acute Ischemic Stroke After Endovascular Treatment w/Doppler

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07013396
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TCD measurement — OTHER
    TCD measurement will be collected with TCD low frequency MHz probes. All TCD operations will be performed by a trained sonographer to assess bilateral MCA, ACA, PCA, Siph, and OA. TCD examinations will be performed as soon as possible after EVT, daily for 3 days and, when possible, as close to any reported neurological deterioration or CT brain scan performed within 72 hours of EVT.
  • TCD parameters — OTHER
    TCD parameters are PSV, EDV, MFV, and PI. Sampling volume will be 5-10 mm, and the monitoring depth on transtemporal windows will be adjusted to gather appropriate vessel segment, e.g. 20-30 mm in the leptomeningeal flow, 40-50 mm in the distal MCA, 50-60 mm in the proximal MCA, 70-75 mm in the ACA, 62-70 mm in PCA, and transorbital, including 60-64 mm in the Siph and 50-60 mm in the OA. TAMMV and PI will be automatically derived from preset. Additionally, flow diversion will be assessed as an indirect indicator of arterial occlusion or severe stenosis in the middle cerebral artery (M1). It will be identified by TCD based on the following criteria: (1) low-resistance flow pattern in the anterior or posterior cerebral artery, and (2) mean flow velocity in the ACA or PCA greater than or equal to that in the MCA.
  • Baseline characteristics — OTHER
    Baseline characteristics will be collected, including age, sex, ethnicity, history of HTN, DM, DLP, CHF, AF, CA, CKD, previous CAD, cirrhosis, mRS, previous stroke or TIA, current antiplatelet usage, current anticoagulant usage, smoking, and alcohol status. This data will be collected through a combination of verbal interviews with participants/LAR legally authorized representatives and a review of their medical history charts.
  • Clinical data will be collected — OTHER
    Clinical data will be collected, including blood pressure values before, during, and after TCD as well as, Door to needle, Door to groin, Groin to first pass, time from recanalization to TCD, baseline NIHSS, site of occlusion, infarct core volume, mismatch volume, mismatch ratio, and IVT treatment status. Classification of stroke etiologies will be collected based on widely accepted TOAST criteria categorized in large vessel atherosclerosis (LAA), cardio-embolism (CE), small vessel occlusion (SAO), Stroke of other determined etiology (SOC), and stroke of undetermined etiology (SUC) \[30\]. This data will be collected by reviewing medical charts from EHR coded as part of standard care.
  • All follow-up patients receive a phone call — OTHER
    All follow-up patients receive a phone call as part of standard post thrombectomy care from the stroke nurses to gather modified Rankin Scale at 7 days and 90 days since hospital discharge.

Study Details

Endovascular therapy (EVT) has proven to be more beneficial for patients with AIS caused by large vessel occlusions (LVO) than medical management alone. A recent meta-analysis of 5 RCTs showed that EVT significantly reduced disability at 90 days compared to medical management \[1\]. Despite its obvious benefits, patients may have neurological deterioration despite successful thrombectomy due to ischemia progression, intracranial hemorrhage, re-occlusion, or vasogenic edema. The incidence of early neurological deterioration (END) following EVT for acute stroke has been reported to be ranging from 14.1-35.2% with some studies defining END up to 7 days and some restricting the definition between 6-72 hours post thrombectomy. A small proportion of these patients, approximately 5.9-10.5%, experienced sICH following EVT. Whether END occurs due to ischemic or hemorrhagic it leads to worse outcomes.

Key Dates

Start date
Feb 28, 2027
Status verified
Nov 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Anterior circulation stroke that underwent EVT including tandem occlusions
    Subjects with anterior circulation stroke including ACA, MCA or ICA stroke that underwent EVT including tandem occlusions

Primary Outcome Measure

Determine correlation between transcranial Doppler (TCD) parameters [ Time Frame: Within 72 hours of any large vessel occlusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23235
Song Srisilpa
[email protected]
845-906-1921
Aarti Sarwal (PRINCIPAL_INVESTIGATOR)

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By research site
Virginia Commonwealth University· Richmond, VA

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