Ischemic Stroke, AcuteNCT06920303
Accuracy of Transcranial Colour Coded Duplex in Comparing With CT Angiography
An observational study of Ischemic Stroke, Acute, run by Sohag University at 1 site in Egypt.
Trial summary
Investigator will compare accuracy of transcranial colour coded duplex with CT angiography in detecting arterial obstructions in patients presenting or with history of cerebrovascular ischemic strokes Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- transcranial colour coded duplex
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Sep 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: one hundred cases of patients with acute ischemiac cerebrovascular stroke will be included in the study
Who may be able to join
- patients who have acute ischemic strokes or transient ischemic attacks .
Who cannot join
- Patients with history of cardiac arrhythmia or discovered recently or known rheumatic heart disease.
- Patients with history of autoimmune diseases.
- Patients with space occupying lesion or hemorrhage in Ct brain.
- Pregnant female.
- Patients who refuse to participate in the study.
- Patients who have history of allergy or developed acute kidney injury during previous dye injection.
Show all 10Show fewer
- Patients who have chronic kidney disease.
- Premorbid neurological disorder (myopathy, multiple sclerosis) on neurological examination or previous investigations.
- Inability to achieve safe vascular access.
- Patients with insufficient temporal acoustic window.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hassan H Accuracy of Transcranial Colour Coded duplex Compared With CT, resident contact
Hazem K Ebrahim, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, professor
About this study
Official title: Accuracy of Transcranial Colour Coded Duplex Compared With CT Angiography in Diagnosing Arterial Obstructions in Acute Ischemic Strokes
Investigator will compare accuracy of transcranial colour coded duplex with CT angiography in detecting arterial obstructions in patients presenting or with history of cerebrovascular ischemic strokes
Read the detailed description
Cerebrovascular stroke is one of the most common causes of death and disability in the World. It accounts for almost 5% of all disability-adjusted life-years and 10% of all deaths worldwide.
Atherosclerosis is one of the major causes of ischemic stroke, it can lead to cerebrovascular stroke through progressive stenosis, occlusion of the extra or intracranial vessels and or arterio-arterial embolization from an atheromatous plaque.
Intracranial stenosis presents with one or recurrent ischemic strokes and transient ischemic attacks.
High-grade stenosis contributes to both the occurrence and magnitude of ischemic injury.
Overall, 50% of patients have either lacunar, subcortical, or cortical infarction.
The remaining patients with intracranial stenosis have multiple lesions involving a combination of cortical, subcortical, and lacunar infarctions.
There are extensive data about carotid atherosclerosis from American, European and Asian population. However, data from Egyptian ethnics are extremely rare.
Ethnic-racial factors are related to the development of extra- and intracranial atherosclerosis.
Intracranial stenosis causes about 10% of strokes in white people, 20-29% of transient ischemic attacks or strokes in black people, and up to 40-50% of strokes in Asian people.
Extracranial atherosclerosis is common among Caucasian stroke patients. For example, in the United States and Western communities, extracranial carotid artery disease was estimated to be responsible for 20-30% of strokes, while less common in Asian and African populations.
Intracranial arterial stenosis is prevalent in the Egyptian stroke population, similar to most non-white populations.
Transcranial Doppler is routinely performed to assess the blood flow in patients with cerebral ischaemia and provides important real-time information about cerebral haemodynamics.
Transcranial doppler can aid in the diagnostic work-up by detecting, localising and grading the severity of intracranial arterial obstruction.
Transcranial Doppler is an established tool for the non-invasive assessment of cerebral blood flow. Since transcranial doppler results vary with the skills and experience of the sonographer, it requires validation against contrast angiography.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- transcranial colour coded duplex
- Keywords
- transcranial colour coded duplex, ct angiography
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial colour coded duplexDevice
transcranial colour coded duplex is good non invasive tool in detect velocity and obstructions of intracranial arteries
| Study group | Role | What they receive |
|---|---|---|
| patients who suffer from ischemic cerebrovascular stroke | All subjects must meet the following criteria to be enrolled in the study, patients who have ischemic strokes or transient ischemic attacks and will be admitted in department of neurology and psychological medicine and stroke unit at Sohag university hospital. Receives: Device: transcranial colour coded duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect accuracy of transcranial color coded duplex compared with CT angiography in diagnosing arterial obstructions in acute ischemic stroke
investigator will detect if transcranial color coded duplex can be used for diagnosing arterial obstructions in acute ischemic stroke by measuring the peak systolic velocity of different intracranial arteries, investigator will compare with CT angiography imaging results to assess the accuracy of transcranial color coded duplex in diagnosis of acute ischemic stroke.
Measured: one year after enrolling one hundred cases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Sep 2026 (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 Ischemic Stroke, AcuteStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Hamdy Hamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920303
- Sponsor's protocol ID
- Soh-Med--25-3-01MS
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
1. DALYs GBD, Collaborators H. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1859-922. 2. Johansson BB. Hypertension mechanisms causing stroke. Clin Exp Pharmacol Physiol. 1999;26(7):563-5.. 3. Grau AJ, Weimar C, Buggle F, Heinrich A, Goertler M, Neumaier S, et al. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank. Stroke. 2001;32(11):2559-66.. 4. Meseguer E, Lavallee PC, Mazighi M, et al. Yield of systematic transcranial Doppler in patients with transient ischemic attack. Ann Neurol 2010;68:9-17.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Transcranial Colour Coded Duplex Compared With CT Angiography in Diagnosing Arterial Obstructions in Acute Ischemic Strokes
- ClinicalTrials.gov ID
- NCT06920303
- Acronym / sponsor ID
- Soh-Med--25-3-01MS
- Conditions
- Ischemic Stroke, Acute
- Keywords
- transcranial colour coded duplex, ct angiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 Apr 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.
Investigator will compare accuracy of transcranial colour coded duplex with CT angiography in detecting arterial obstructions in patients presenting or with history of cerebrovascular ischemic strokes
Detailed description
Cerebrovascular stroke is one of the most common causes of death and disability in the World. It accounts for almost 5% of all disability-adjusted life-years and 10% of all deaths worldwide.
Atherosclerosis is one of the major causes of ischemic stroke, it can lead to cerebrovascular stroke through progressive stenosis, occlusion of the extra or intracranial vessels and or arterio-arterial embolization from an atheromatous plaque.
Intracranial stenosis presents with one or recurrent ischemic strokes and transient ischemic attacks.
High-grade stenosis contributes to both the occurrence and magnitude of ischemic injury.
Overall, 50% of patients have either lacunar, subcortical, or cortical infarction.
The remaining patients with intracranial stenosis have multiple lesions involving a combination of cortical, subcortical, and lacunar infarctions.
There are extensive data about carotid atherosclerosis from American, European and Asian population. However, data from Egyptian ethnics are extremely rare.
Ethnic-racial factors are related to the development of extra- and intracranial atherosclerosis.
Intracranial stenosis causes about 10% of strokes in white people, 20-29% of transient ischemic attacks or strokes in black people, and up to 40-50% of strokes in Asian people.
Extracranial atherosclerosis is common among Caucasian stroke patients. For example, in the United States and Western communities, extracranial carotid artery disease was estimated to be responsible for 20-30% of strokes, while less common in Asian and African populations.
Intracranial arterial stenosis is prevalent in the Egyptian stroke population, similar to most non-white populations.
Transcranial Doppler is routinely performed to assess the blood flow in patients with cerebral ischaemia and provides important real-time information about cerebral haemodynamics.
Transcranial doppler can aid in the diagnostic work-up by detecting, localising and grading the severity of intracranial arterial obstruction.
Transcranial Doppler is an established tool for the non-invasive assessment of cerebral blood flow. Since transcranial doppler results vary with the skills and experience of the sonographer, it requires validation against contrast angiography.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who suffer from ischemic cerebrovascular stroke | – | Device: transcranial colour coded duplexAll subjects must meet the following criteria to be enrolled in the study, patients who have ischemic strokes or transient ischemic attacks and will be admitted in department of neurology and psychological medicine and stroke unit at Sohag university hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- one hundred cases of patients with acute ischemiac cerebrovascular stroke will be included in the study
Key inclusion criteria (1 listed)
- patients who have acute ischemic strokes or transient ischemic attacks .
Key exclusion criteria (10 listed)
- Patients with history of cardiac arrhythmia or discovered recently or known rheumatic heart disease.
- Patients with history of autoimmune diseases.
- Patients with space occupying lesion or hemorrhage in Ct brain.
- Pregnant female.
- Patients who refuse to participate in the study.
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 colour coded duplextranscranial colour coded duplex is good non invasive tool in detect velocity and obstructions of intracranial arteries | Device | patients who suffer from ischemic cerebrovascular stroke |
Primary outcome
detect accuracy of transcranial color coded duplex compared with CT angiography in diagnosing arterial obstructions in acute ischemic stroke
Time frame: one year after enrolling one hundred cases
investigator will detect if transcranial color coded duplex can be used for diagnosing arterial obstructions in acute ischemic stroke by measuring the peak systolic velocity of different intracranial arteries, investigator will compare with CT angiography imaging results to assess the accuracy of transcranial color coded duplex in diagnosis of acute ischemic stroke.
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 13 May 2025.
- Background1. DALYs GBD, Collaborators H. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1859-922. 2. Johansson BB. Hypertension mechanisms causing stroke. Clin Exp Pharmacol Physiol. 1999;26(7):563-5.. 3. Grau AJ, Weimar C, Buggle F, Heinrich A, Goertler M, Neumaier S, et al. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank. Stroke. 2001;32(11):2559-66.. 4. Meseguer E, Lavallee PC, Mazighi M, et al. Yield of systematic transcranial Doppler in patients with transient ischemic attack. Ann Neurol 2010;68:9-17.
- Individual participant dataSharing planned: Undecided
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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.
Hassan H Accuracy of Transcranial Colour Coded duplex Compared With CT, resident contact
Hazem K Ebrahim, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hassan H Accuracy of Transcranial Colour Coded duplex Compared With CT, resident (+2001060583440, hassan.hamdy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect accuracy of transcranial color coded duplex compared with CT angiography in diagnosing arterial obstructions in acute ischemic stroke (time frame: one year after enrolling one hundred cases). 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 NCT06920303, 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 13 May 2025.