- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03252652
Normal Parameters of Cranial Vessels Using Cranial Vascular Duplex Among Egyptian Population
Standardization of Normal Parameters of Cranial Vessels by Using Extra and Trans Cranial Vascular Duplex Among Egyptian Population
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Tverrsnitt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Normal intimal-medial thickness measured in millimeter
Tidsramme: 24 months
|
Estimation of the intimal-medial thickness for cranial vessels.
|
24 months
|
|
Normal vessels' diameter measured in millimeter
Tidsramme: 24 months
|
Estimation of the vessels' diameter
|
24 months
|
|
Normal peak flow velocity measured in cm/sec
Tidsramme: 24 months
|
peak flow velocity both systolic and diastolic for cranial vessels
|
24 months
|
|
Normal indices
Tidsramme: 24 months
|
pulsatility index and resistance index for cranial vessels
|
24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Early detection of subjects at risk of atherosclerosis
Tidsramme: 24 months
|
detection of subjects with early atherosclerotic changes for further management
|
24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mostafa H Ghazally, MBChB, Assiut University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SNPCUETCDE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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-
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