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Status unknownNCT03252652Updated Aug 17, 2017

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

An observational study in Atherosclerosis, Atheroma of Cerebral Arteries and Atheroma; Carotid Artery, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atherosclerosis
  • Atheroma of Cerebral Arteries
  • Atheroma; Carotid Artery
  • Atheroma; Cerebral

Keywords

  • Cranial vessels
  • Normal parameters
  • Carotid Duplex
  • Egyptian
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Egyptian population

Inclusion criteria

  • Normal subjects between 20-40 years

Exclusion criteria

Exclusion Criteria:

  • Diabetic patients, hypertensive patients, any evidence of vascular disease either peripheral or central, subjects refusing to participate
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Radiationvascular duplex ultrasound imaging

    Duplex ultrasound is a non-invasive evaluation of blood flow through cranial arteries and veins.

05

What researchers measure

Primary outcomes

  1. Normal intimal-medial thickness measured in millimeter

    Estimation of the intimal-medial thickness for cranial vessels.

    Time frame: 24 months

  2. Normal vessels' diameter measured in millimeter

    Estimation of the vessels' diameter

    Time frame: 24 months

  3. Normal peak flow velocity measured in cm/sec

    peak flow velocity both systolic and diastolic for cranial vessels

    Time frame: 24 months

  4. Normal indices

    pulsatility index and resistance index for cranial vessels

    Time frame: 24 months

Secondary outcomes

  1. Early detection of subjects at risk of atherosclerosis

    detection of subjects with early atherosclerotic changes for further management

    Time frame: 24 months

06

Study locations

No study locations are listed for this record.

07

References and documents

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 15470212 ↗
  • 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. doi: 10.1161/hs1101.098524. PubMed 11692017 ↗
  • 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. doi: 10.1161/01.str.23.4.486. PubMed 1561677 ↗
  • 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. PubMed 24094043 ↗
08

Registry details

Key details

Study ID
NCT03252652
Lead sponsor
Assiut University
Responsible party
Mostafa Mohammed Hamdy Ghazally (principle investigator, Assiut University) — Principal investigator
First posted
Aug 17, 2017
Start date
Oct 2017 (estimated)
Primary completion
Aug 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Aug 17, 2017

Study contacts

Tarek A Rageh, PHD
Contact
Tarek_rageh@hotmail.com
+0201223849203
Khaled O Abosheira, PHD
Contact
+0201003012229
Mostafa H Ghazally, MBChB
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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