Cerebrovascular StrokeNCT05920291
Carotid Doppler Findings of High Risk Group of Stroke
An observational study of Cerebrovascular Stroke, run by Assiut University.
Trial summary
To evaluate the effect of different risk factors on carotid arteries via ultrasonography parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Stroke
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2023to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: A study of group of individuals taken from general population who have high risk factors of stroke such as diabetes, hypertension, obesity, and smoking. The sample size will be at least 85 patients.
Who may be able to join
- Adults.
- People with risk factors for cerebrovascular stroke such as diabetics, hypertensive, smokers and obese person.
Who cannot join
- Children.
- People with no risk factors for cerebrovascular strokes.
- People with past history of cerebrovascular stroke.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Predictive Value of Carotid Doppler Ultrasound Findings for Stroke Risk Assessmen
To evaluate the effect of different risk factors on carotid arteries via ultrasonography parameters.
Read the detailed description
Atherosclerosis of carotid arteries is a common serious condition that develops when sticky plaque builds up inside carotid arteries that deliver blood to brain, so carotid artery diseases cause about 10-20 percent of strokes which is a medical emergency that can leave the brain with permanent damage.
Doppler sonography of the cervical segment of carotid arteries is a popular non-invasive tool for evaluation of anatomy and hemodynamics of carotid artery (1), its ability to measure intimal media thickening and characterizes the morphology of carotid atheroma makes it a reliable modality to determine the etiology and severity of stroke (3), (4). Carotid intimal media thickening is measured as the distance between the leading edges of the two echogenic layers of the wall using the posterior wall (5), in addition color Doppler ultrasonography permits measurement of flow based on reflection of ultrasound waves utilizing both pulse Doppler and color Doppler ultrasound. Visualization of color coded flow information about direction and velocity, so with high grade lesions are more easily detected with color than with pulsed Doppler ultrasound although the later allows direct estimation of flow velocity The peak systolic velocity (PSV) is used for quantification of stenosis, however end diastolic velocity (EDV), carotid index and spectral wave form analysis are also used for assessment of stenosis (6).
Also, color integration is used to identify areas of abnormal flow. There are a number of pitfalls when using velocity based estimation of ICA stenosis, such as higher velocities in females, and elevated velocities where there's contra lateral carotid artery occlusion .(7_9) If there is a severe tortuosity of an artery, high carotid bifurcation, obesity, or extensive calcification of the vasculature, these will reduce the sonographic accuracy; if carotid artery stents are already in situ , vessel wall compliance can be diminished accelerating flow velocity.(10) Ultrasound may also be unable to distinguish between partial and complete vessel occlusion, despite the distinction being critically clinically important. (10-12).
In this study we present analysis of findings of carotid ultrasound examination among patients with clinical suspicion and risk for cerebrovascular diseases in New Valley.
Ultrasonography in this study is used to measure intimal thickening as well as flow characteristics of carotid artery with focus on internal carotid artery.
Extra cranial vessels represent vessels outside the brain and the skull. The most common configuration is the three-vessel arch anatomy, where the first branch is the brachiocephalic artery which further branches into the right common carotid artery (CCA) and right subclavian artery. The second branch is the left common carotid artery, with the left subclavian artery as the third branch. (13) The most common variant to this anatomy is the common origin of brachiocephalic and left CCA from aortic arch. The common carotid arteries bifurcate into the external carotid artery (ECA) and internal carotid artery (ICA)at the upper border of the thyroid. The carotid bulb is the location of a bifurcation and the ICA origin. (14) ICA is generally posterior and lateral to ECA and is usually bigger in caliber compared to ECA. ECA supplies the musculature of face and neck and tapers distally giving off extra cranial branches. (15).
Coloured Doppler sonography using 5-10 MHZ multifrequency linear transducer, the scan is performed in both transverse and longitudinal dimensions.
The patients are scanned in supine position on the examination table, the patient's head is turned away from the side and the neck a little extended. The examination is carried out either from the patient's Side or sitting at the patient's head. Coupling gel is applied on each side of the neck.
Gray scale imaging, which is also Called B (brightness) mode is usually performed first where the carotid arteries are evaluated in their entirety from the jugular notch to angle of the mandible (16).B_mode imaging evaluates the coarse and caliber of the vessel with evaluation of intimal media thickness and quality of the plaque , the morphology of the plaque is associated with the severity of atherosclerotic diseases (17). At the jugular notch the transducer angulated caudally, while at the mandible it's cephalic angulated.
This is followed by Doppler examination (18,19) Many parameters should be adjusted to achieve reliable results, Doppler angle should be less than 60 degrees (as close as possible to parallel) to improve accuracy of measurements. (20) The calculated velocity will be incorrect if calculated using inaccurate angle, the velocity of CCA is usually 30-40 cm/sec but may vary in diseased vessel. (21) Gain is adjusted so that color is seen only within the lumen of the vessel to avoid bleeding artifact. (22) Sample volume should be placed in to center of the lumen and should be moved along the entire vessel. Any abrupt change in the systolic velocity or area of slow flow should be carefully evaluated and documented.1(23) Spectral analysis including peak systolic velocity (PSV), peak diastolic velocity (PDV), main maximum velocity, and pulsatiliy index can be obtained. Spectral Doppler wave form evaluation gives critical information about flow dynamics at the point of sampling, which depends on hemodynamic factors affect proximal and distal portion of the vessel. (24) ICA demonstrates low resistance flow, ECA has high resistance flow, while CCA has a hybrid of ICA and ECA. The resistive index is used to describe wave form, which signifies resistance of the vessel distal to the examined vessel. (25) Spectral Doppler should be evaluated at minimum at (a) proximal, mid, and distal common carotid artery (b) proximal, mid and distal internal carotid artery (c) proximal carotid artery (d)vertebral artery, any significant stenosis should be carefully evaluated and documented distal and proximal to the stenosis.(26,27) Peak systolic velocity (PSV) greater than 125cm/S correlates with 50%or higher ICA stenosis (28) PSV greater than 230cm/s correlates with 70% or higher stenosis a potential indication for surgical endarterectomy.
- Conditions
- Cerebrovascular Stroke
- Keywords
- Carotid Doppler.
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of carotid arteries with focus on internal carotid artery
normal ICA PSV is <125 cm/sec and no plaque or intimal thickening is visible sonographically additional criteria include ICA/CCA PSV ratio <2.0 and ICA EDV <40 cm/sec. <50% ICA stenosis ICA PSV is <125 cm/sec and plaque or intimal thickening is visible sonographically additional criteria include ICA/CCA PSV ratio <2.0 and ICA EDV <40 cm/sec. 50-69% ICA stenosis ICA PSV is 125-230 cm/sec and plaque is visible sonographically additional criteria include ICA/CCA PSV ratio of 2.0-4.0 and ICA EDV of 40-100 cm/sec.
≥70% ICA stenosis but less than near occlusion ICA PSV is >230 cm/sec and visible plaque and luminal narrowing are seen at gray-scale and color Doppler ultrasound ) additional criteria include ICA/CCA PSV ratio >4 and ICA EDV >100 cm/sec. near occlusion of the ICA diagnosis is established primarily by demonstrating a markedly narrowed lumen at color or power Doppler ultrasound.
total occlusion of the ICA: no detectable patent lumen at gray-scale ultrasound
Measured: Base line
Secondary outcomes (1)
Risk factors are recorded
Age Gender Race Family history Hypertension Smoking Diabetes mellitus Obesity
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start20 Jul 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehad Bakr Haroun Ahmed, Assiut University
- Investigators
- Gehan Sayed Ahmed, Study director, Assiut UniversityAbdel-Monem Sayed Hasan, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920291
- Sponsor's protocol ID
- Carotid Doppler
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kau T, Sinzig M, Gasser J, Lesnik G, Rabitsch E, Celedin S, Eicher W, Illiasch H, Hausegger KA. Aortic development and anomalies. Semin Intervent Radiol. 2007 Jun;24(2):141-52. doi: 10.1055/s-2007-980040.
PubMed 21326792Dungan DH, Heiserman JE. The carotid artery: embryology, normal anatomy, and physiology. Neuroimaging Clin N Am. 1996 Nov;6(4):789-99.
PubMed 8824131FRANKLIN DL, SCHLEGEL W, RUSHMER RF. Blood flow measured by Doppler frequency shift of back-scattered ultrasound. Science. 1961 Aug 25;134(3478):564-5. doi: 10.1126/science.134.3478.564.
PubMed 13701432
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Carotid Doppler Ultrasound Findings for Stroke Risk Assessmen
- ClinicalTrials.gov ID
- NCT05920291
- Acronym / sponsor ID
- Carotid Doppler
- Conditions
- Cerebrovascular Stroke
- Keywords
- Carotid Doppler.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 27 Jun 2023 (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.
To evaluate the effect of different risk factors on carotid arteries via ultrasonography parameters.
Detailed description
Atherosclerosis of carotid arteries is a common serious condition that develops when sticky plaque builds up inside carotid arteries that deliver blood to brain, so carotid artery diseases cause about 10-20 percent of strokes which is a medical emergency that can leave the brain with permanent damage.
Doppler sonography of the cervical segment of carotid arteries is a popular non-invasive tool for evaluation of anatomy and hemodynamics of carotid artery (1), its ability to measure intimal media thickening and characterizes the morphology of carotid atheroma makes it a reliable modality to determine the etiology and severity of stroke (3), (4). Carotid intimal media thickening is measured as the distance between the leading edges of the two echogenic layers of the wall using the posterior wall (5), in addition color Doppler ultrasonography permits measurement of flow based on reflection of ultrasound waves utilizing both pulse Doppler and color Doppler ultrasound. Visualization of color coded flow information about direction and velocity, so with high grade lesions are more easily detected with color than with pulsed Doppler ultrasound although the later allows direct estimation of flow velocity The peak systolic velocity (PSV) is used for quantification of stenosis, however end diastolic velocity (EDV), carotid index and spectral wave form analysis are also used for assessment of stenosis (6).
Also, color integration is used to identify areas of abnormal flow. There are a number of pitfalls when using velocity based estimation of ICA stenosis, such as higher velocities in females, and elevated velocities where there's contra lateral carotid artery occlusion .(7_9) If there is a severe tortuosity of an artery, high carotid bifurcation, obesity, or extensive calcification of the vasculature, these will reduce the sonographic accuracy; if carotid artery stents are already in situ , vessel wall compliance can be diminished accelerating flow velocity.(10) Ultrasound may also be unable to distinguish between partial and complete vessel occlusion, despite the distinction being critically clinically important. (10-12).
In this study we present analysis of findings of carotid ultrasound examination among patients with clinical suspicion and risk for cerebrovascular diseases in New Valley.
Ultrasonography in this study is used to measure intimal thickening as well as flow characteristics of carotid artery with focus on internal carotid artery.
Extra cranial vessels represent vessels outside the brain and the skull. The most common configuration is the three-vessel arch anatomy, where the first branch is the brachiocephalic artery which further branches into the right common carotid artery (CCA) and right subclavian artery. The second branch is the left common carotid artery, with the left subclavian artery as the third branch. (13) The most common variant to this anatomy is the common origin of brachiocephalic and left CCA from aortic arch. The common carotid arteries bifurcate into the external carotid artery (ECA) and internal carotid artery (ICA)at the upper border of the thyroid. The carotid bulb is the location of a bifurcation and the ICA origin. (14) ICA is generally posterior and lateral to ECA and is usually bigger in caliber compared to ECA. ECA supplies the musculature of face and neck and tapers distally giving off extra cranial branches. (15).
Coloured Doppler sonography using 5-10 MHZ multifrequency linear transducer, the scan is performed in both transverse and longitudinal dimensions.
The patients are scanned in supine position on the examination table, the patient's head is turned away from the side and the neck a little extended. The examination is carried out either from the patient's Side or sitting at the patient's head. Coupling gel is applied on each side of the neck.
Gray scale imaging, which is also Called B (brightness) mode is usually performed first where the carotid arteries are evaluated in their entirety from the jugular notch to angle of the mandible (16).B_mode imaging evaluates the coarse and caliber of the vessel with evaluation of intimal media thickness and quality of the plaque , the morphology of the plaque is associated with the severity of atherosclerotic diseases (17). At the jugular notch the transducer angulated caudally, while at the mandible it's cephalic angulated.
This is followed by Doppler examination (18,19) Many parameters should be adjusted to achieve reliable results, Doppler angle should be less than 60 degrees (as close as possible to parallel) to improve accuracy of measurements. (20) The calculated velocity will be incorrect if calculated using inaccurate angle, the velocity of CCA is usually 30-40 cm/sec but may vary in diseased vessel. (21) Gain is adjusted so that color is seen only within the lumen of the vessel to avoid bleeding artifact. (22) Sample volume should be placed in to center of the lumen and should be moved along the entire vessel. Any abrupt change in the systolic velocity or area of slow flow should be carefully evaluated and documented.1(23) Spectral analysis including peak systolic velocity (PSV), peak diastolic velocity (PDV), main maximum velocity, and pulsatiliy index can be obtained. Spectral Doppler wave form evaluation gives critical information about flow dynamics at the point of sampling, which depends on hemodynamic factors affect proximal and distal portion of the vessel. (24) ICA demonstrates low resistance flow, ECA has high resistance flow, while CCA has a hybrid of ICA and ECA. The resistive index is used to describe wave form, which signifies resistance of the vessel distal to the examined vessel. (25) Spectral Doppler should be evaluated at minimum at (a) proximal, mid, and distal common carotid artery (b) proximal, mid and distal internal carotid artery (c) proximal carotid artery (d)vertebral artery, any significant stenosis should be carefully evaluated and documented distal and proximal to the stenosis.(26,27) Peak systolic velocity (PSV) greater than 125cm/S correlates with 50%or higher ICA stenosis (28) PSV greater than 230cm/s correlates with 70% or higher stenosis a potential indication for surgical endarterectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A study of group of individuals taken from general population who have high risk factors of stroke such as diabetes, hypertension, obesity, and smoking. The sample size will be at least 85 patients.
Key inclusion criteria (2 listed)
- Adults.
- People with risk factors for cerebrovascular stroke such as diabetics, hypertensive, smokers and obese person.
Key exclusion criteria (3 listed)
- Children.
- People with no risk factors for cerebrovascular strokes.
- People with past history of cerebrovascular stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of carotid arteries with focus on internal carotid artery
Time frame: Base line
normal ICA PSV is <125 cm/sec and no plaque or intimal thickening is visible sonographically additional criteria include ICA/CCA PSV ratio <2.0 and ICA EDV <40 cm/sec. <50% ICA stenosis ICA PSV is <125 cm/sec and plaque or intimal thickening is visible sonographically additional criteria include ICA/CCA PSV ratio <2.0 and ICA EDV <40 cm/sec. 50-69% ICA stenosis ICA PSV is 125-230 cm/sec and plaque is visible sonographically additional criteria include ICA/CCA PSV ratio of 2.0-4.0 and ICA EDV of 40-100 cm/sec. ≥70% ICA stenosis but less than near occlusion ICA PSV is >230 cm/sec and visible plaque and luminal narrowing are seen at gray-scale and color Doppler ultrasound ) additional criteria include ICA/CCA PSV ratio >4 and ICA EDV >100 cm/sec. near occlusion of the ICA diagnosis is established primarily by demonstrating a markedly narrowed lumen at color or power Doppler ultrasound. total occlusion of the ICA: no detectable patent lumen at gray-scale ultrasound
1 secondary outcome
Risk factors are recorded
Time frame: Base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Results publication: PubMed 21326792Kau T, Sinzig M, Gasser J, Lesnik G, Rabitsch E, Celedin S, Eicher W, Illiasch H, Hausegger KA. Aortic development and anomalies. Semin Intervent Radiol. 2007 Jun;24(2):141-52. doi: 10.1055/s-2007-980040.
- Results publication: PubMed 8824131Dungan DH, Heiserman JE. The carotid artery: embryology, normal anatomy, and physiology. Neuroimaging Clin N Am. 1996 Nov;6(4):789-99.
- Results publication: PubMed 13701432FRANKLIN DL, SCHLEGEL W, RUSHMER RF. Blood flow measured by Doppler frequency shift of back-scattered ultrasound. Science. 1961 Aug 25;134(3478):564-5. doi: 10.1126/science.134.3478.564.
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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. This study is not recruiting at the moment.
Gehan Sayed Ahmed study director
Assiut University
Abdel-Monem Sayed Hasan study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Stroke, run by Assiut University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehad Bakr HAROUN (01007777918 ext. 002, Nehadbakr007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of carotid arteries with focus on internal carotid artery (time frame: Base line). 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 NCT05920291, which also lists 3 linked publications.
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 27 Jun 2023.