- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00514644
Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE) (SPACE)
Stroke and Panorama - Analyzing Carotid Endocalcifications
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We intend to examinate 100 consecutive persons that have calcifications in the area of the carotid arteries with carotid duplex-ultrasound. The prevalence of carotid stenoses > 50% (According to the NASCET criteria) in this group is the primary result of interest, answering the most fundamental question - should persons with calcifications in the area of the carotid arteries seen on panorama be screened with ultrasound in order to find asymptomatic carotid stenoses? Since the publication of the ACST and the ACAS studies it is clear that some of these patients might have indications for surgery.
A second part of the study aims to more fully understand what it is that the panorama examination reveals. In this part will 100 patients that are going to undergo surgery to remove their carotid stenoses will be examined with panorama. The carotid plaque that is removed during the surgery will be examined radiologically.
Primary endpoint:
- Subpopulation prevalence of carotid stenoses > 50% in persons with calcifications in the area of the carotid arteries seen in a panoramic examination.
Secondary endpoints:
- Statistical data (sensitivity, specificity, accuracy, likelihood ratio and predictive values) for panorama to find carotid stenoses with ultrasound as gold standard.
- Qualitative description of the relationship between panoramic calcification images and the removed carotid plaques.
AMENDMENT JUNE 2011: The different arms of the study will be published seperately.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Västerbotten
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Umea, Västerbotten, Sverige, 901 85
- University Hospital in Umea
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Panorama to Ultrasound arm:
- Calcifications in the area of the carotid arteries seen och panorama
Ultrasound to Panorama arm:
- Known carotid stenosis > 50%
- Must undergo carotid endoarterectomy after the panoramic examination
Exclusion Criteria:
Panorama to Ultrasound arm:
- Previous cerebrovascular symptoms
- Below 18 or above 75 years of age
Ultrasound to Panorama arm:
- Below 18 or above 90 years of age
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Panorama to Ultrasound
100 asymptotic patients that have findings of calcifications in the area of the carotid arteries when examined with panorama.
These persons are examined with carotid ultrasound.
|
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
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Eksperimentel: Ultrasound to Panorama
100 patients with a known carotid stenosis seen on ultrasound will be examined with panorama before any intervention is made.
These patients must undergo surgery to be finally included.
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Examination with the odontological radiological method "Panorama", including a frontal verification image
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Per G Wester, Prof., Umea University
- Ledende efterforsker: Jan Ahlqvist, Docent, Umea University
- Ledende efterforsker: Eva Levring Jäghagen, Lector, Umea University
- Ledende efterforsker: Elias P Johansson, PhD Student, Umea University
Publikationer og nyttige links
Generelle publikationer
- Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. doi: 10.1002/14651858.CD001923.
- Yin D, Carpenter JP. Cost-effectiveness of screening for asymptomatic carotid stenosis. J Vasc Surg. 1998 Feb;27(2):245-55. doi: 10.1016/s0741-5214(98)70355-6.
- Almog DM, Horev T, Illig KA, Green RM, Carter LC. Correlating carotid artery stenosis detected by panoramic radiography with clinically relevant carotid artery stenosis determined by duplex ultrasound. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Dec;94(6):768-73. doi: 10.1067/moe.2002.128965.
- Friedlander AH, Garrett NR, Chin EE, Baker JD. Ultrasonographic confirmation of carotid artery atheromas diagnosed via panoramic radiography. J Am Dent Assoc. 2005 May;136(5):635-40; quiz 682-3. doi: 10.14219/jada.archive.2005.0235.
- Johansson EP, Ahlqvist J, Garoff M, Karp K, Jaghagen EL, Wester P. Ultrasound screening for asymptomatic carotid stenosis in subjects with calcifications in the area of the carotid arteries on panoramic radiographs: a cross-sectional study. BMC Cardiovasc Disord. 2011 Jul 13;11:44. doi: 10.1186/1471-2261-11-44.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EJ-8404
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