StrokeTRADE-AISNCT07004790
Prognostic Value of Transcranial Doppler Ultrasound in the Clinical Evolution of Patients With Acute Ischemic Stroke. The TRADE-AIS Study
A study testing Transcranial Doppler Ultrasound in people with Stroke, run by Jose Ivan Rodriguez de Molina Serrano.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial Doppler Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, MSc, Ph, Crit Care sp contact
About this study
Official title: Prognostic Value of Transcranial Doppler Ultrasound in the Clinical Evolution of Patients With Acute Ischemic Stroke: A Prospective Observational Study
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.
Read the detailed description
TRADE-AIS (Transcranial Doppler Evaluation - Acute Ischemic Stroke) is a prospective, single-center, observational cohort study designed to evaluate the prognostic value of transcranial Doppler ultrasound (TCD) in patients with acute ischemic stroke (AIS). The study will be conducted at Clínica México, a secondary-level hospital located in Piedras Negras, Coahuila, Mexico.
Upon presentation to the emergency department or inpatient stroke unit, patients diagnosed with AIS will undergo a baseline neurological examination, including NIH Stroke Scale (NIHSS) scoring. A transcranial Doppler ultrasound will then be performed within 24 hours of symptom onset. The TCD protocol will include insonation of the middle cerebral arteries (MCAs), anterior and posterior communicating arteries, and basilar artery, using a 2-MHz probe via the temporal window.
Parameters to be recorded include:
Mean flow velocity (Vm) in the MCA
Pulsatility index (PI)
Presence and pattern of collateral flow (e.g., via anterior communicating artery)
Abnormal waveforms such as reverberant, absent, or blunted flow
Patients will be clinically monitored throughout their hospital stay. Follow-up NIHSS scoring will be conducted at 72 hours. Functional status at discharge will be assessed using the modified Rankin Scale (mRS). The primary aim is to correlate early hemodynamic findings with short-term neurological evolution. Secondary aims include assessing the association of collateral circulation with clinical improvement and determining whether TCD-derived indices can serve as non-invasive prognostic markers.
All diagnostic and therapeutic decisions (e.g., reperfusion therapy, ICU admission) will be made by the attending medical team independently of study procedures. No experimental interventions are included.
The study intends to demonstrate that early bedside neurosonology can provide clinically relevant prognostic information, particularly useful in settings with limited access to advanced imaging modalities like CT perfusion or MRI.
Data will be collected and managed using encrypted case report forms. Statistical analysis will include correlation tests and multivariate regression models to adjust for clinical covariates.
The primary outcome is the correlation between baseline MCA flow velocity and the change in NIHSS score at 72 hours. Secondary outcomes include:
The association between collateral circulation and clinical improvement,
Functional status at hospital discharge, assessed using the modified Rankin Scale (mRS).
The study will take place over 12 months at Clínica México, a secondary-level hospital located in Piedras Negras, Coahuila, Mexico. The study is non-interventional: all treatment decisions, including eligibility for thrombolysis or endovascular therapy, are made by the attending clinical team and are not influenced by study participation.
This investigation is designed to assess the prognostic value of TCD as a non-invasive, bedside tool for early risk stratification in AIS, particularly in settings with limited access to advanced neuroimaging.
- Conditions
- Stroke
- Being tested
- Transcranial Doppler Ultrasound
- Keywords
- stroke, transcranial doppler, Prognosis, Middle Cerebral Artery, Cerebral Hemodynamics, Mexico
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler UltrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Transcranial Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (2)
Presence of collateral circulation associated with ≥ 4-point NIHSS improvement
Collateral circulation will be assessed using transcranial Doppler ultrasound within 24 hours of symptom onset. Collaterals will be defined as the presence of cross-flow or increased velocity in the anterior or posterior communicating arteries. Clinical improvement is defined as a reduction of ≥4 points on the NIHSS score from baseline to day 7. The association between collateral flow and neurological improvement will be analyzed.
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.
Measured: 7 days
Functional status at discharge (modified Rankin Scale)
The patient's functional outcome will be assessed at discharge using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death). The distribution of mRS scores will be analyzed in relation to transcranial Doppler findings, including mean flow velocity, pulsatility index, and flow pattern, to determine their prognostic significance.
Measured: At hospital discharge (within 14 days of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Ivan Rodriguez de Molina Serrano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Ivan Rodriguez de Molina Serrano, Clinica Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004790
- Sponsor's protocol ID
- CMX0004
- Acronym
- TRADE-AIS
- Status last verified
- Sep 2025
- First submitted
- 27 May 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided.
Publications
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.
PubMed 17238867
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Transcranial Doppler Ultrasound in the Clinical Evolution of Patients With Acute Ischemic Stroke: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07004790
- Acronym / sponsor ID
- TRADE-AIS / CMX0004
- Conditions
- Stroke
- Keywords
- stroke, transcranial doppler, Prognosis, Middle Cerebral Artery, Cerebral Hemodynamics, Mexico
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jose Ivan Rodriguez de Molina SerranoUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TRADE-AIS (Transcranial Doppler Evaluation - Acute Ischemic Stroke) is a prospective, single-center, observational cohort study designed to evaluate the prognostic value of transcranial Doppler ultrasound (TCD) in patients with acute ischemic stroke (AIS). The study will be conducted at Clínica México, a secondary-level hospital located in Piedras Negras, Coahuila, Mexico.
Upon presentation to the emergency department or inpatient stroke unit, patients diagnosed with AIS will undergo a baseline neurological examination, including NIH Stroke Scale (NIHSS) scoring. A transcranial Doppler ultrasound will then be performed within 24 hours of symptom onset. The TCD protocol will include insonation of the middle cerebral arteries (MCAs), anterior and posterior communicating arteries, and basilar artery, using a 2-MHz probe via the temporal window.
Parameters to be recorded include:
Mean flow velocity (Vm) in the MCA
Pulsatility index (PI)
Presence and pattern of collateral flow (e.g., via anterior communicating artery)
Abnormal waveforms such as reverberant, absent, or blunted flow
Patients will be clinically monitored throughout their hospital stay. Follow-up NIHSS scoring will be conducted at 72 hours. Functional status at discharge will be assessed using the modified Rankin Scale (mRS). The primary aim is to correlate early hemodynamic findings with short-term neurological evolution. Secondary aims include assessing the association of collateral circulation with clinical improvement and determining whether TCD-derived indices can serve as non-invasive prognostic markers.
All diagnostic and therapeutic decisions (e.g., reperfusion therapy, ICU admission) will be made by the attending medical team independently of study procedures. No experimental interventions are included.
The study intends to demonstrate that early bedside neurosonology can provide clinically relevant prognostic information, particularly useful in settings with limited access to advanced imaging modalities like CT perfusion or MRI.
Data will be collected and managed using encrypted case report forms. Statistical analysis will include correlation tests and multivariate regression models to adjust for clinical covariates.
The primary outcome is the correlation between baseline MCA flow velocity and the change in NIHSS score at 72 hours. Secondary outcomes include:
The association between collateral circulation and clinical improvement,
Functional status at hospital discharge, assessed using the modified Rankin Scale (mRS).
The study will take place over 12 months at Clínica México, a secondary-level hospital located in Piedras Negras, Coahuila, Mexico. The study is non-interventional: all treatment decisions, including eligibility for thrombolysis or endovascular therapy, are made by the attending clinical team and are not influenced by study participation.
This investigation is designed to assess the prognostic value of TCD as a non-invasive, bedside tool for early risk stratification in AIS, particularly in settings with limited access to advanced neuroimaging.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inpatient Stroke confirmed | Other | Diagnostic Test: Transcranial Doppler UltrasoundAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler UltrasoundA 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. | Diagnostic test | Inpatient Stroke confirmed |
Primary outcome
Change in NIHSS score from baseline to 72 hours
Time frame: 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.
2 secondary outcomes
Presence of collateral circulation associated with ≥ 4-point NIHSS improvement
Time frame: 7 days
Functional status at discharge (modified Rankin Scale)
Time frame: At hospital discharge (within 14 days of admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 17238867Alexandrov 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.
- Individual participant dataSharing planned: Undecided. Not decided.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, MSc, Ph, Crit Care sp contact
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Doppler Ultrasound in people with Stroke, run by Jose Ivan Rodriguez de Molina Serrano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, MSc, Ph, Crit Care sp (878 782 12 89 ext. 208, jefe.urgencias@clinicamexico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIHSS score from baseline to 72 hours (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.