About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Anterior circulation stroke including ACA, MCA or ICA stroke that underwent EVT including tandem occlusions.
Age ≥ 18 years
Disqualifiers
Difficulty in detecting the acoustic window by TCD
Pregnancy
Incarcerated patients
Trial design
Single group
Treatments tested in this trial
TCD measurement
Other interventionTCD 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 interventionTCD 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 interventionBaseline 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 interventionClinical 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 interventionAll 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Discharge Disposition
Discharge disposition (discharge to home, acute rehabilitation, skilled nursing facility, long-term acute care facility, hospice/palliative care/death). It is the final place or setting to which the patient was discharged on the day of discharge.
Modified Rankin Scale
Modified Rankin scale closest to 3 months. The Modified Rankin Scale (mRS) is a 6-point disability scale used to measure the degree of disability or dependence in activities of daily living after a stroke or other neurological disability. It is a widely used outcome measure in stroke clinical trials and clinical care. 0-2: Indicate mild to moderate disability, with patients being largely independent. 3-5: Indicate moderate to severe disability, requiring assistance with daily activities. 6: Indicates death.
Interaction between collateral circulation status and mean arterial pressure
To investigate the interaction between collateral circulation status and mean arterial pressure (MAP) in relation to predicting risk of END within 72 hours. In the context of cerebral stroke, the relationship between collateral circulation status and mean arterial pressure (MAP) is complex and significant. Poor collateral circulation, particularly in the case of acute large vessel occlusion (LVO), increases the dependence of blood flow on MAP. Cerebral autoregulation, the brain's ability to maintain constant blood flow despite changes in MAP, is impaired during LVO. This means that even within the typical autoregulation range (50-150 mmHg), the brain's ability to compensate for blood pressure fluctuations is reduced.
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