NCT05920291

Brief Summary

To evaluate the effect of different risk factors on carotid arteries via ultrasonography parameters.

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
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

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

April 5, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

April 5, 2023

Last Update Submit

June 23, 2023

Conditions

Keywords

Carotid Doppler.

Outcome Measures

Primary Outcomes (1)

  • Evaluation of carotid arteries with focus on internal carotid artery

    normal ICA PSV is \<125 cm/sec and no plaque or intimal thickening is visible sonographically additional criteria include ICA/CCA PSV ratio \<2.0 and ICA EDV \<40 cm/sec. \<50% ICA stenosis ICA PSV is \<125 cm/sec and plaque or intimal thickening is visible sonographically additional criteria include ICA/CCA PSV ratio \<2.0 and ICA EDV \<40 cm/sec. 50-69% ICA stenosis ICA PSV is 125-230 cm/sec and plaque is visible sonographically additional criteria include ICA/CCA PSV ratio of 2.0-4.0 and ICA EDV of 40-100 cm/sec. ≥70% ICA stenosis but less than near occlusion ICA PSV is \>230 cm/sec and visible plaque and luminal narrowing are seen at gray-scale and color Doppler ultrasound ) additional criteria include ICA/CCA PSV ratio \>4 and ICA EDV \>100 cm/sec. near occlusion of the ICA diagnosis is established primarily by demonstrating a markedly narrowed lumen at color or power Doppler ultrasound. total occlusion of the ICA: no detectable patent lumen at gray-scale ultrasound

    Base line

Secondary Outcomes (1)

  • Risk factors are recorded

    Base line

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A study of group of individuals taken from general population who have high risk factors of stroke such as diabetes, hypertension, obesity, and smoking. The sample size will be at least 85 patients.

You may qualify if:

  • Adults.
  • People with risk factors for cerebrovascular stroke such as diabetics, hypertensive, smokers and obese person.

You may not qualify if:

  • Children.
  • People with no risk factors for cerebrovascular strokes.
  • People with past history of cerebrovascular stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kau T, Sinzig M, Gasser J, Lesnik G, Rabitsch E, Celedin S, Eicher W, Illiasch H, Hausegger KA. Aortic development and anomalies. Semin Intervent Radiol. 2007 Jun;24(2):141-52. doi: 10.1055/s-2007-980040.

  • Dungan DH, Heiserman JE. The carotid artery: embryology, normal anatomy, and physiology. Neuroimaging Clin N Am. 1996 Nov;6(4):789-99.

  • FRANKLIN DL, SCHLEGEL W, RUSHMER RF. Blood flow measured by Doppler frequency shift of back-scattered ultrasound. Science. 1961 Aug 25;134(3478):564-5. doi: 10.1126/science.134.3478.564.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gehan Sayed Ahmed

    Assiut University

    STUDY DIRECTOR
  • Abdel-Monem Sayed Hasan

    Assiut University

    STUDY CHAIR

Central Study Contacts

Nehad Bakr HAROUN

CONTACT

Abdel-Monem Sayed Hasan

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at radiodiagnosis department

Study Record Dates

First Submitted

April 5, 2023

First Posted

June 27, 2023

Study Start

July 20, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06