Normal Parameters of Cranial Vessels Using Cranial Vascular Duplex Among Egyptian Population

Atherosclerosis Clinical Trial

Official title:

Standardization of Normal Parameters of Cranial Vessels by Using Extra and Trans Cranial Vascular Duplex Among Egyptian Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03252652
• Other study ID #: SNPCUETCDE
• Status: Not yet recruiting
• Phase: N/A
• First received: August 8, 2017
• Last updated: August 16, 2017
• Start date: October 2017
• Est. completion date: October 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Tarek A Rageh, PHD
• Phone: +0201223849203
• Email: Tarek_rageh[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the study will be carried out to standardize normal parameters of vascular duplex ultrasound of the cranial vessels in the Egyptian population.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atheroma of Cerebral Arteries
• Atheroma; Carotid Artery
• Atheroma; Cerebral
• Atherosclerosis
• Carotid Artery Diseases
• Intracranial Arteriosclerosis
• Plaque, Atherosclerotic

Intervention

Radiation:
• vascular duplex ultrasound imaging
Duplex ultrasound is a non-invasive evaluation of blood flow through cranial arteries and veins.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Grau 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. — View 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. — View Citation

Timsit 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal intimal-medial thickness measured in millimeter	Estimation of the intimal-medial thickness for cranial vessels.	24 months
Primary	Normal vessels' diameter measured in millimeter	Estimation of the vessels' diameter	24 months
Primary	Normal peak flow velocity measured in cm/sec	peak flow velocity both systolic and diastolic for cranial vessels	24 months
Primary	Normal indices	pulsatility index and resistance index for cranial vessels	24 months
Secondary	Early detection of subjects at risk of atherosclerosis	detection of subjects with early atherosclerotic changes for further management	24 months