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Titolo:
Carotid MR angiography: Phase II study of safety and efficacy for MS-325
Autore:
Bluemke, DA; Stillman, AE; Bis, KG; Grist, TM; Baum, RA; DAgostino, R; Malden, ES; Pierro, JA; Yucel, EK;
Indirizzi:
Johns Hopkins Univ, Sch Med, Dept Radiol, Baltimore, MD 21287 USA Johns Hopkins Univ Baltimore MD USA 21287 Radiol, Baltimore, MD 21287 USA Cleveland Clin, Dept Radiol, Cleveland, OH USA Cleveland Clin Cleveland OH USA and Clin, Dept Radiol, Cleveland, OH USA William Beaumont Hosp, Dept Radiol, Royal Oak, MI 48072 USA William Beaumont Hosp Royal Oak MI USA 48072 iol, Royal Oak, MI 48072 USA Univ Wisconsin, Dept Radiol, Madison, WI 53706 USA Univ Wisconsin MadisonWI USA 53706 n, Dept Radiol, Madison, WI 53706 USA Hosp Univ Penn, Dept Radiol, Philadelphia, PA 19104 USA Hosp Univ Penn Philadelphia PA USA 19104 diol, Philadelphia, PA 19104 USA Univ Vermont, Dept Radiol, Fletcher Allen Hlth Care, Burlington, VT 05405 USA Univ Vermont Burlington VT USA 05405 Hlth Care, Burlington, VT 05405 USA Washington Univ, Med Ctr, Mallinckrodt Inst Radiol, St Louis, MO 63110 USAWashington Univ St Louis MO USA 63110 Inst Radiol, St Louis, MO 63110 USA EPIX Med, Cambridge, MA USA EPIX Med Cambridge MA USAEPIX Med, Cambridge, MA USA
Titolo Testata:
RADIOLOGY
fascicolo: 1, volume: 219, anno: 2001,
pagine: 114 - 122
SICI:
0033-8419(200104)219:1<114:CMAPIS>2.0.ZU;2-4
Fonte:
ISI
Lingua:
ENG
Soggetto:
MAGNETIC-RESONANCE ANGIOGRAPHY; CT ANGIOGRAPHY; CONTRAST AGENT; STENOSIS; ARTERIES; BIFURCATION; DISEASE; DSA; 2D;
Keywords:
carotid arteries, MR; carotid arteries, stenosis or obstruction; contrast media, experimental studies; magnetic resonance (MR), contrast media; magnetic resonance (MR), vascular studies;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
33
Recensione:
Indirizzi per estratti:
Indirizzo: Bluemke, DA Johns Hopkins Univ, Sch Med, Dept Radiol, 600 N Wolfe St, Baltimore, MD 21287 USA Johns Hopkins Univ 600 N Wolfe St Baltimore MD USA 21287 7 USA
Citazione:
D.A. Bluemke et al., "Carotid MR angiography: Phase II study of safety and efficacy for MS-325", RADIOLOGY, 219(1), 2001, pp. 114-122

Abstract

PURPOSE: To evaluate the safety and efficacy of MS-325 in patients suspected of having carotid arterial disease. MATERIALS AND METHODS: Fifty carotid arteries in 26 patients were imaged with three-dimensional spoiled gradient-recalled-echo magnetic resonance (MR) angiography at 5 and 50 minutes after injection of MS-325. MS-325 was administered intravenously as a single dose of 0.01, 0.03, or 0.05 mmol per kilogram of body weight as determined with a dose randomization scheme for four, nine, and 13 patients, respectively. Safety, including clinical laboratory changes and electrocardiographic monitoring, was assessed until approximately 3 days after injection. Conventional contrast agent-enhanced angiography was used as the standard of reference. Independent readers blinded to the dose interpreted the MR angiographic and conventional images. Images were assessed for location and extent of carotid arterial stenosis. RESULTS: There were no severe or serious adverse events. For the determination of clinically significant stenosis (>70%) on the 5-minute images, sensitivity, specificity, and accuracy (P = .07, three-way comparison) were 100%, 100%, and 100%; 63%, 100%, and 88%; and 40%, 75%, and 55% at 0.01, 0.03,and 0.05 mmol/kg, respectively. Sensitivity and specificity for images at 50 minutes after MS-325 administration showed the same trends as the 5-minute images. CONCLUSION: Overall accuracy for MS-325-enhanced carotid MR angiography performed during steady-state conditions of circulating contrast agent approximately 5 minutes after injection was high (88%-100%) at 0.03 and 0.61 mmol/kg. MS-325 was well tolerated at all evaluated doses.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 06/04/20 alle ore 02:14:12