NCT03252652

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

August 8, 2017

Last Update Submit

August 16, 2017

Conditions

AtherosclerosisAtheroma of Cerebral ArteriesAtheroma; Carotid ArteryAtheroma; Cerebral

Keywords

Cranial vesselsNormal parametersCarotid DuplexEgyptian

Outcome Measures

Primary Outcomes (4)

  • Normal intimal-medial thickness measured in millimeter

    Estimation of the intimal-medial thickness for cranial vessels.

    24 months

  • Normal vessels' diameter measured in millimeter

    Estimation of the vessels' diameter

    24 months

  • Normal peak flow velocity measured in cm/sec

    peak flow velocity both systolic and diastolic for cranial vessels

    24 months

  • Normal indices

    pulsatility index and resistance index for cranial vessels

    24 months

Secondary Outcomes (1)

  • Early detection of subjects at risk of atherosclerosis

    24 months

Interventions

vascular duplex ultrasound imagingRADIATION

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Egyptian population

You may qualify if:

  • Normal subjects between 20-40 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 15470212BACKGROUND

  • 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.

    PMID: 11692017BACKGROUND

  • 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.

    PMID: 1561677BACKGROUND

  • 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.

    PMID: 24094043BACKGROUND

MeSH Terms

Conditions

AtherosclerosisCarotid Artery DiseasesPlaque, Atherosclerotic

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mostafa H Ghazally, MBChB

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek A Rageh, PHD

CONTACT

+0201223849203Tarek_rageh@hotmail.com

Khaled O Abosheira, PHD

CONTACT

+0201003012229

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 17, 2017

Study Start

October 1, 2017

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

August 17, 2017

Record last verified: 2017-08