AtherosclerosisNCT03252652
Normal Parameters of Cranial Vessels Using Cranial Vascular Duplex Among Egyptian Population
An observational study of Atherosclerosis and Atheroma of Cerebral Arteries, run by Assiut University.
Trial summary
the study will be carried out to standardize normal parameters of vascular duplex ultrasound of the cranial vessels in the Egyptian population. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Atheroma of Cerebral Arteries, Atheroma; Carotid Artery
- What is being tested?
- vascular duplex ultrasound imaging
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Oct 2019
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Egyptian population
Who may be able to join
- Normal subjects between 20-40 years
Who cannot join
- Diabetic patients, hypertensive patients, any evidence of vascular disease either peripheral or central, subjects refusing to participate
Trial locations and contacts
No sites are listed yet.
Khaled O Abosheira, PHD contact
About this study
Official title: Standardization of Normal Parameters of Cranial Vessels by Using Extra and Trans Cranial Vascular Duplex Among Egyptian Population
the study will be carried out to standardize normal parameters of vascular duplex ultrasound of the cranial vessels in the Egyptian population.
Read the detailed description
Atherosclerosis is a major cause of ischemic stroke and a significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaques. Several studies have reported racial differences in the severity and distribution of carotid atherosclerosis. In the United States and Western communities, Extra-cranial carotid artery disease was estimated to be responsible for 20-30% of strokes. Little is known about the prevalence and distribution of carotid disease among the populations in the developing countries.
Vascular duplex ultrasound is a useful, cheap and available diagnostic tool for assessing cranial vascular disease. Duplex ultrasound can be highly reliable with proper technique, without the risk of radiation in other imaging modalities, is well tolerated by all patients including those who are claustrophobic in MRI machines, and has much less risks compared to conventional angiography studies.
Although vascular duplex has been used for years yet there is little researches had been done on normal population in the developing countries to collect results and compare it to the parameters that was collected and reviewed in the western developed populations.
The parameters that would be used in this study include both the data collected by static and dynamic duplex scan which are the intimal-medial thickness, the vessels' diameter, peak flow velocity and peak flow volume both systolic and diastolic for either extra- or intra-cranial vessels.
- Conditions
- Atherosclerosis, Atheroma of Cerebral Arteries, Atheroma; Carotid Artery, Atheroma; Cerebral
- Being tested
- vascular duplex ultrasound imaging
- Keywords
- Cranial vessels, Normal parameters, Carotid Duplex, Egyptian
- Medical subject headings
- Atherosclerosis, Carotid Artery Diseases, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular duplex ultrasound imagingRadiation
Duplex ultrasound is a non-invasive evaluation of blood flow through cranial arteries and veins.
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal intimal-medial thickness measured in millimeter
Estimation of the intimal-medial thickness for cranial vessels.
Measured: 24 months
Normal vessels' diameter measured in millimeter
Estimation of the vessels' diameter
Measured: 24 months
Normal peak flow velocity measured in cm/sec
peak flow velocity both systolic and diastolic for cranial vessels
Measured: 24 months
Normal indices
pulsatility index and resistance index for cranial vessels
Measured: 24 months
Secondary outcomes (1)
Early detection of subjects at risk of atherosclerosis
detection of subjects with early atherosclerotic changes for further management
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startOct 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohammed Hamdy Ghazally, Assiut University
- Investigators
- Mostafa H Ghazally, MBChB, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252652
- Sponsor's protocol ID
- SNPCUETCDE
- Status last verified
- Aug 2017
- First submitted
- 8 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K; Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004 Oct 7;351(15):1493-501. doi: 10.1056/NEJMoa040127.
PubMed 15470212Grau AJ, Weimar C, Buggle F, Heinrich A, Goertler M, Neumaier S, Glahn J, Brandt T, Hacke W, Diener HC. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank. Stroke. 2001 Nov;32(11):2559-66. doi: 10.1161/hs1101.098524.
PubMed 11692017Timsit SG, Sacco RL, Mohr JP, Foulkes MA, Tatemichi TK, Wolf PA, Price TR, Hier DB. Early clinical differentiation of cerebral infarction from severe atherosclerotic stenosis and cardioembolism. Stroke. 1992 Apr;23(4):486-91. doi: 10.1161/01.str.23.4.486.
PubMed 1561677Svicero DJ, Doiche DP, Mamprim MJ, Heckler MC, Amorim RM. Ultrasound evaluation of common carotid artery blood flow in the Labrador retriever. BMC Vet Res. 2013 Oct 7;9:195. doi: 10.1186/1746-6148-9-195.
PubMed 24094043
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Normal Parameters of Cranial Vessels by Using Extra and Trans Cranial Vascular Duplex Among Egyptian Population
- ClinicalTrials.gov ID
- NCT03252652
- Acronym / sponsor ID
- SNPCUETCDE
- Conditions
- Atherosclerosis, Atheroma of Cerebral Arteries, Atheroma; Carotid Artery, Atheroma; Cerebral
- Keywords
- Cranial vessels, Normal parameters, Carotid Duplex, Egyptian
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 17 Aug 2017 (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.
the study will be carried out to standardize normal parameters of vascular duplex ultrasound of the cranial vessels in the Egyptian population.
Detailed description
Atherosclerosis is a major cause of ischemic stroke and a significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaques. Several studies have reported racial differences in the severity and distribution of carotid atherosclerosis. In the United States and Western communities, Extra-cranial carotid artery disease was estimated to be responsible for 20-30% of strokes. Little is known about the prevalence and distribution of carotid disease among the populations in the developing countries.
Vascular duplex ultrasound is a useful, cheap and available diagnostic tool for assessing cranial vascular disease. Duplex ultrasound can be highly reliable with proper technique, without the risk of radiation in other imaging modalities, is well tolerated by all patients including those who are claustrophobic in MRI machines, and has much less risks compared to conventional angiography studies.
Although vascular duplex has been used for years yet there is little researches had been done on normal population in the developing countries to collect results and compare it to the parameters that was collected and reviewed in the western developed populations.
The parameters that would be used in this study include both the data collected by static and dynamic duplex scan which are the intimal-medial thickness, the vessels' diameter, peak flow velocity and peak flow volume both systolic and diastolic for either extra- or intra-cranial vessels.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Egyptian population
Key inclusion criteria (1 listed)
- Normal subjects between 20-40 years
Key exclusion criteria (1 listed)
- Diabetic patients, hypertensive patients, any evidence of vascular disease either peripheral or central, subjects refusing to participate
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 |
|---|---|---|
| vascular duplex ultrasound imagingDuplex ultrasound is a non-invasive evaluation of blood flow through cranial arteries and veins. | Radiation | – |
Primary outcome
Normal intimal-medial thickness measured in millimeter
Time frame: 24 months
Estimation of the intimal-medial thickness for cranial vessels.
Normal vessels' diameter measured in millimeter
Time frame: 24 months
Estimation of the vessels' diameter
Normal peak flow velocity measured in cm/sec
Time frame: 24 months
peak flow velocity both systolic and diastolic for cranial vessels
Normal indices
Time frame: 24 months
pulsatility index and resistance index for cranial vessels
1 secondary outcome
Early detection of subjects at risk of atherosclerosis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Background: PubMed 15470212Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K; Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004 Oct 7;351(15):1493-501. doi: 10.1056/NEJMoa040127.
- Background: PubMed 11692017Grau AJ, Weimar C, Buggle F, Heinrich A, Goertler M, Neumaier S, Glahn J, Brandt T, Hacke W, Diener HC. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank. Stroke. 2001 Nov;32(11):2559-66. doi: 10.1161/hs1101.098524.
- Background: PubMed 1561677Timsit SG, Sacco RL, Mohr JP, Foulkes MA, Tatemichi TK, Wolf PA, Price TR, Hier DB. Early clinical differentiation of cerebral infarction from severe atherosclerotic stenosis and cardioembolism. Stroke. 1992 Apr;23(4):486-91. doi: 10.1161/01.str.23.4.486.
- Background: PubMed 24094043Svicero DJ, Doiche DP, Mamprim MJ, Heckler MC, Amorim RM. Ultrasound evaluation of common carotid artery blood flow in the Labrador retriever. BMC Vet Res. 2013 Oct 7;9:195. doi: 10.1186/1746-6148-9-195.
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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.
Khaled O Abosheira, PHD contact
Mostafa H Ghazally, MBChB principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Atheroma of Cerebral Arteries, 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 1 inclusion and 1 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 17 Aug 2017. 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 Tarek A Rageh, PHD (+0201223849203, Tarek_rageh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal intimal-medial thickness measured in millimeter (time frame: 24 months). The study lists 4 primary outcomes in all. 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 NCT03252652, which also lists 4 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 17 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.