Clinical trial NCT03252652: Normal Parameters of Cranial Vessels Using Cranial Vascular Duplex Among Egyptian Population
Official title: Standardization of Normal Parameters of Cranial Vessels by Using Extra and Trans Cranial Vascular Duplex Among Egyptian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Atheroma of Cerebral Arteries
Atheroma; Carotid Artery
Atheroma; Cerebral
Keywords: Cranial vessels
Normal parameters
Carotid Duplex
Egyptian
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian population

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Normal subjects between 20-40 years

Exclusion Criteria:

* Diabetic patients, hypertensive patients, any evidence of vascular disease either peripheral or central, subjects refusing to participate

Primary outcomes:
measure: Normal intimal-medial thickness measured in millimeter
timeFrame: 24 months
measure: Normal vessels' diameter measured in millimeter
timeFrame: 24 months
measure: Normal peak flow velocity measured in cm/sec
timeFrame: 24 months
measure: Normal indices
timeFrame: 24 months
Secondary outcomes:
measure: Early detection of subjects at risk of atherosclerosis
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mostafa H Ghazally, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Svicero 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.