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

NCT07013396 | Not Yet Recruiting

• 1 other identifier: HM20032561
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cerebral Artery Syndrome; Anterior Cerebral Artery Stroke; Acute Ischemic Stroke; Cardioembolic Stroke; Vasogenic Cerebral Edema

Keywords

systolic blood pressure; Transcranial Doppler; Large Vessel Occlusion; mean flow velocity; early neurological deterioration; cerebral hemodynamics; endovascular thrombectomy; cerebral autoregulation; blood pressure management; collateral circulation; pulsatility index; peak systolic velocity; end-diastolic velocity; Modified Rankin Scale

Outcome Measures

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.

  Within 72 hours after EVT

Secondary Outcomes (3)

• Post-EVT NIHSS score at 24 hours and discharge

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

• Number of participants by discharge disposition category

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

• Functional outcome by modified Rankin Scale at 90 days

  90 days

Study Arms (1)

Anterior circulation LVO stroke treated with EVT

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

Other: Transcranial Doppler (TCD) examination

Interventions

Transcranial Doppler (TCD) examination OTHER

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.

Anterior circulation LVO stroke treated with EVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Infarction, Anterior Cerebral Artery; Ischemic Stroke; Embolic Stroke; Brain Edema

Interventions

Ultrasonography, Doppler, Transcranial; Restraint, Physical

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques; Behavior Control; Therapeutics; Immobilization

Study Officials

• Aarti Sarwal

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Srivastava

CONTACT

804-828-9499; tarun.srivastava1@vcuhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)