Transcranial Doppler Evaluation After Endovascular Thrombectomy for Acute Ischemic Stroke (PRECISE-TCD)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

About this trial

Endovascular thrombectomy (EVT) improves outcomes in acute ischemic stroke caused by large vessel occlusion. Despite successful recanalization, early neurological deterioration (END) remains frequent and is associated with poor outcomes. Transcranial Doppler (TCD) provides noninvasive, real-time assessment of cerebral blood flow velocities and may identify hemodynamic patterns associated with deterioration after EVT. PRECISE-TCD is a prospective, single-center observational study enrolling 180-300 patients undergoing EVT for anterior circulation large vessel occlusion at a tertiary academic medical center. Serial TCD examinations are performed immediately after EVT, daily for 72 hours, and as close as possible to early neurological deterioration events or clinically indicated head CT within 72 hours. The primary outcome is the association between TCD-derived hemodynamic parameters and END within 72 hours. Secondary outcomes include NIHSS at 24 hours and discharge, discharge disposition, and modified Rankin Scale at 90 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Anterior circulation large vessel occlusion, including ACA, MCA, or ICA stroke, treated with endovascular thrombectomy, including tandem occlusions

Age ≥ 18 years

Ability to detect an adequate acoustic window via TCD.

Disqualifiers

Inadequate acoustic windows defined as lack of bilateral MCA signal at standard depths.

Pregnancy

Incarceration

Trial population

Adults with anterior circulation large vessel occlusion, including ACA, MCA, or ICA stroke, treated with endovascular thrombectomy at VCU Medical Center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcranial Doppler (TCD) examination

    Other intervention

    Serial non-invasive TCD monitoring will be performed as soon as possible after EVT, daily for 72 hours, and when possible, close to any neurological deterioration or head CT obtained within 72 hours after EVT. TCD parameters include PSV, EDV, MFV, and PI measured in bilateral MCA, ACA, PCA, carotid siphon, vertebrobasilar arteries, and ophthalmic artery territories. Collateralization patterns, including ACA flow reversal, ophthalmic artery flow reversal, and high-flow ACA or PCA patterns relative to MCA flow, will also be assessed.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Anterior circulation LVO stroke treated with EVT1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of early neurological deterioration (END) within 72 hours after EVT

Early neurological deterioration (END) will be assessed as a binary Yes/No outcome. A participant will be classified as having END if any of the following occurs within 72 hours after endovascular thrombectomy (EVT): an increase in total NIHSS score of ≥4 points; an increase in NIHSS item 1a score of ≥1 point; intracranial hemorrhage on CT or MRI classified using the Heidelberg Classification; or any neurological examination change prompting emergent head CT at clinician discretion. The outcome will be reported as the percentage of participants who meet the criteria for END.

Time frame
Within 72 hours after EVT

Secondary outcomes

1

Post-EVT NIHSS score at 24 hours and discharge

Post-EVT National Institutes of Health Stroke Scale (NIHSS) score will be assessed at 24 hours and at hospital discharge.

Time frame
24 hours after EVT and at discharge from the index hospitalization, assessed up to 30 days post-EVT
2

Number of participants by discharge disposition category

Discharge disposition will be obtained from the medical record and categorized as home, acute rehabilitation, long-term acute care facility, skilled nursing facility, or hospice/palliative care/death. The outcome will be reported as the number of participants in each discharge disposition category.

Time frame
At discharge from the index hospitalization, assessed up to 30 days post-EVT
3

Functional outcome by modified Rankin Scale at 90 days

Functional outcome will be assessed by phone-based modified Rankin Scale (mRS) at 90 days. Good outcome is defined as mRS 0-2, and poor outcome is defined as mRS 3-6.

Time frame
90 days

Other outcomes

Sponsors and contacts

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