Prognostic Value of Transcranial Doppler Ultrasound in the Clinical Evolution of Patients With Acute Ischemic Stroke. The TRADE-AIS Study

NCT07004790 | Not Yet Recruiting

• 1 other identifier: CMX0004
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational study aims to determine whether specific parameters measured by transcranial Doppler ultrasound (TCD) can predict clinical outcomes in patients with acute ischemic stroke (AIS). The primary objective is to evaluate the association between middle cerebral artery (MCA) flow velocities and short-term neurological improvement. Secondary outcomes include the presence of collateral flow and flow patterns in relation to functional recovery measured by NIHSS and modified Rankin Scale (mRS) scores.

Conditions

Stroke

Keywords

stroke; transcranial doppler; Prognosis; Middle Cerebral Artery; Cerebral Hemodynamics; Mexico

Outcome Measures

Primary Outcomes (1)

• Change in NIHSS score from baseline to 72 hours

  Neurological status will be assessed using the National Institutes of Health Stroke Scale (NIHSS) at baseline (upon admission) and again at 72 hours. The primary objective is to evaluate the correlation between initial transcranial Doppler (TCD) measurements-specifically, mean flow velocity and pulsatility index in the middle cerebral artery-and the degree of clinical improvement or deterioration, as reflected by changes in NIHSS score. A greater reduction in NIHSS score indicates better neurological recovery. The NIH Stroke Scale (NIHSS) is a standardized, 15-item clinical assessment tool used to evaluate the severity of neurologic deficits in patients with acute stroke. The total NIHSS score ranges from 0 to 42, where: 0 = no stroke symptoms Higher scores indicate greater stroke severity and worse neurological outcomes The scale includes assessments of level of consciousness, gaze, visual fields, motor strength, limb ataxia, sensory function, language, and neglect.

  72 hours

Secondary Outcomes (2)

• Presence of collateral circulation associated with ≥ 4-point NIHSS improvement

  7 days

• Functional status at discharge (modified Rankin Scale)

  At hospital discharge (within 14 days of admission)

Study Arms (1)

Inpatient Stroke confirmed

OTHER

All participants diagnosed with acute ischemic stroke will undergo standard clinical evaluation and transcranial Doppler ultrasound within 24 hours of symptom onset. No interventions are assigned by the study. Clinical and hemodynamic data will be collected to assess prognostic associations with short-term outcomes. All patients are managed according to routine care protocols determined by the attending medical team.

Diagnostic Test: Transcranial Doppler Ultrasound

Interventions

Transcranial Doppler Ultrasound DIAGNOSTIC_TEST

A non-invasive bedside diagnostic procedure used to measure cerebral blood flow velocities and pulsatility index in intracranial arteries, primarily the middle cerebral artery (MCA). The test is performed within the first 24 hours of symptom onset using standard ultrasound equipment with a 2-MHz probe. The data collected is used solely for prognostic evaluation and does not influence treatment decisions.

Inpatient Stroke confirmed

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Clinical diagnosis of acute ischemic stroke
• Onset of symptoms ≤ 24 hours before admission
• Underwent or will undergo transcranial Doppler ultrasound within 24 hours of symptom onset
• Able to provide informed consent or consent obtained from a legal representative

You may not qualify if:

• Evidence of intracerebral hemorrhage on imaging
• Inadequate temporal acoustic window for transcranial Doppler
• Intubated or hemodynamically unstable prior to Doppler evaluation
• Known diagnosis of neurodegenerative disease significantly affecting baseline neurological function (e.g., advanced dementia, Parkinson's disease)
• Refusal to participate or withdrawal of consent

Sponsors & Collaborators

• Jose Ivan Rodriguez de Molina Serrano: lead

Related Publications (1)

• Alexandrov AV, Sloan MA, Wong LK, Douville C, Razumovsky AY, Koroshetz WJ, Kaps M, Tegeler CH; American Society of Neuroimaging Practice Guidelines Committee. Practice standards for transcranial Doppler ultrasound: part I--test performance. J Neuroimaging. 2007 Jan;17(1):11-8. doi: 10.1111/j.1552-6569.2006.00088.x.

  PMID: 17238867 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, MSc, Ph, Crit Care sp

CONTACT

878 782 12 89; jefe.urgencias@clinicamexico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research and Medical Education Clinica Mexico

Model Details: Participants with confirmed acute ischemic stroke will be enrolled consecutively and followed as a single cohort. All participants will undergo baseline clinical assessment and transcranial Doppler ultrasound within 24 hours of symptom onset. No grouping or randomization will be applied. The study will observe natural clinical progression and outcomes without intervention assignment.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09