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

NCT07013396 | Not Yet Recruiting

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

Brief Summary

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.

Conditions

Anterior Cerebral Artery Syndrome; Anterior Cerebral Artery Stroke; Acute Ischemic Stroke; Coronary Artery Disease; Cardioembolic Stroke; Congestive Heart Failure; Diabetes; Vasogenic Cerebral Edema

Keywords

systolic blood pressure; Transcranial Doppler

Outcome Measures

Primary Outcomes (1)

• Determine correlation between transcranial Doppler (TCD) parameters

  Compare peak flow velocity, mean flow velocity, and pulsatility index. Transcranial Doppler (TCD) ultrasound uses sound waves to measure blood flow in the brain's arteries, providing scores that indicate normal flow or potential issues like vasospasm or increased stroke risk. Normal TCD scores for the middle cerebral artery (MCA) range from 55 cm/sec for normal flow, with elevated velocities indicating mild to severe vasospasm.

  Within 72 hours of any large vessel occlusion

Secondary Outcomes (3)

• Discharge Disposition

  Study Duration, 24 months

• Modified Rankin Scale

  3 months

• Interaction between collateral circulation status and mean arterial pressure

  72 hours

Study Arms (1)

Anterior circulation stroke that underwent EVT including tandem occlusions

EXPERIMENTAL

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

Other: TCD measurement; Other: TCD parameters; Other: Baseline characteristics; Other: Clinical data will be collected; Other: All follow-up patients receive a phone call

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.

Anterior circulation stroke that underwent EVT including tandem occlusions

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.

Anterior circulation stroke that underwent EVT including tandem occlusions

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.

Anterior circulation stroke that underwent EVT including tandem occlusions

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.

Anterior circulation stroke that underwent EVT including tandem occlusions

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.

Anterior circulation stroke that underwent EVT including tandem occlusions

Eligibility Criteria

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

You may qualify if:

• Anterior circulation stroke including ACA, MCA or ICA stroke that underwent EVT including tandem occlusions.
• Age ≥ 18 years

You may not qualify if:

• Difficulty in detecting the acoustic window by TCD
• Pregnancy
• Incarcerated patients

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; Coronary Artery Disease; Embolic Stroke; Heart Failure; Diabetes Mellitus; Brain Edema

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; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Aarti Sarwal

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Srisilpa

CONTACT

(845) 906-1921; song.srisilpa@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single center observational study

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)