Gadobutrol Enhanced MRA of the Supra-aortic Vessels (GEMSAV)
Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.
This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.
MRA and CTA images will be collected for an independent review (blinded read).
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Shanghai、中国、200032
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Shanghai、中国、200433
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Seoul、大韩民国、05505
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Seoul、大韩民国、06351
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Seoul、大韩民国、03722
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Gwangju Gwang''yeogsi
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Donggu,、Gwangju Gwang''yeogsi、大韩民国、61469
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Wien、奥地利、1090
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Tirol
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Innsbruck、Tirol、奥地利、6020
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Baden-Württemberg
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Karlsruhe、Baden-Württemberg、德国、76133
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Bayern
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Augsburg、Bayern、德国、865156
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Erlangen、Bayern、德国、91054
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Nordrhein-Westfalen
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Münster、Nordrhein-Westfalen、德国、48145
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Thüringen
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Jena、Thüringen、德国、07740
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Emilia-Romagna
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Ferrara、Emilia-Romagna、意大利、44023
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Lazio
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Roma、Lazio、意大利、00168
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Sicilia
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Catania、Sicilia、意大利、95123
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Toscana
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Massa-Carrara、Toscana、意大利、54100
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Valle d'Aosta
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Aosta、Valle d'Aosta、意大利、11100
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Veneto
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Venezia、Veneto、意大利、30174
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Brno、捷克语、62500
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BRON Cedex、法国、69677
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Brest Cedex、法国、29609
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Marseille、法国、13385
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Paris、法国、75877
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Paris Cedex 15、法国、75908
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Bydgoszcz、波兰、85-094
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Lodz、波兰、90-153
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Warszawa、波兰、02-097
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Wroclaw、波兰、50-556
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New South Wales
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New Lambton Heights、New South Wales、澳大利亚、2305
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Victoria
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Clayton、Victoria、澳大利亚、3168
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Parkville、Victoria、澳大利亚、3052
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Antalya、火鸡、07059
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Erzurum、火鸡、25240
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Istanbul、火鸡、34093
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Linköping、瑞典、581 85
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Uppsala、瑞典、751 85
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Sankt Gallen
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St. Gallen、Sankt Gallen、瑞士、9007
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Arizona
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Tucson、Arizona、美国、85724
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Florida
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Jacksonville、Florida、美国、32209
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Georgia
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Savannah、Georgia、美国、31406
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Kentucky
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Louisville、Kentucky、美国、40202
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Maryland
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Baltimore、Maryland、美国、21201
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Massachusetts
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Boston、Massachusetts、美国、02114
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Michigan
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Ann Arbor、Michigan、美国、48109-0330
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Mississippi
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Jackson、Mississippi、美国、39216
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New York
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Bronx、New York、美国、10467
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Rochester、New York、美国、14642
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
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Rhode Island
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Providence、Rhode Island、美国、02903
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Tennessee
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Memphis、Tennessee、美国、38104
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Washington
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Seattle、Washington、美国、98195
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Wisconsin
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Madison、Wisconsin、美国、53792
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Buenos Aires
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Adrogué、Buenos Aires、阿根廷、B1846DWA
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Ciudad Auton. De Buenos Aires
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Buenos Aires、Ciudad Auton. De Buenos Aires、阿根廷、C1115AAB
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Buenos Aires、Ciudad Auton. De Buenos Aires、阿根廷、C1425BEE
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female subjects, aged 18 years and older
Any of the following:
Known or suspected supra-aortic arterial disease based on:
- Prior stroke
- Transient ischemic attack (TIA)
- Amaurosis Fugax (transient monocular blindness)
- Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
- Follow-up for a stent in a supra-aortic vessel
- Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints.
- Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
- Willingness and ability to follow directions and complete all study procedures specified in the protocol
- Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug
Exclusion Criteria:
- Pregnant or nursing (including pumping for storage and feeding)
- Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
- Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
- Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
- Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
- History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
- Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
- Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
- Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
- Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
- Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)
Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:
- Any procedure that may alter the MRA or CTA interpretation, or
- Any interventional or surgical procedure involving the supra-aortic vessels
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:手臂 1
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A single bolus injection of approx.
0.1mmol/kg
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
大体时间:Images were taken pre-injection and post-injection
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Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers).
A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably.
There were 21 segments of the supra-aortic arteries assessed per participant.
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Images were taken pre-injection and post-injection
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Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
大体时间:Images were taken pre-injection and post-injection
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Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers).
This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.
In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
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Images were taken pre-injection and post-injection
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Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
大体时间:Images were taken pre-injection and post-injection
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Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers).
This was determined using the NASCET criteria.
For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.
In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
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Images were taken pre-injection and post-injection
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Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%
大体时间:Images were taken pre-injection and post-injection
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Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers).
For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.
Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
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Images were taken pre-injection and post-injection
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Minimum Gadobutrol Performance for Specificity: Specificity > 50%
大体时间:Images were taken pre-injection and post-injection
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Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers).
For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.
Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
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Images were taken pre-injection and post-injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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存在伪影的片段的百分比
大体时间:注射前和注射后拍摄图像
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在分段的基础上为 MRA 图像收集伪影。
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注射前和注射后拍摄图像
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临床研究者在评估未增强和钆布醇增强 MRA 图像后推荐的其他影像学检查类型
大体时间:注射前和注射后拍摄图像
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从以下列表中指定了推荐的其他影像学研究:非对比 MRA、对比增强 MRA、CTA、超声、数字减影导管血管造影 (DSCA) 和核医学研究。
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注射前和注射后拍摄图像
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Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
大体时间:Images were taken pre-injection and post-injection
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The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured.
The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment.
Mean of vessel diameters was calculated by segment separately for CTA and MRA readers.
For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).
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Images were taken pre-injection and post-injection
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Types of Artifacts on a Segment Basis by Blinded Reader 1
大体时间:Images were taken pre-injection and post-injection
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The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
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Images were taken pre-injection and post-injection
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Types of Artifacts on a Segment Basis by Blinded Reader 2
大体时间:Images were taken pre-injection and post-injection
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The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
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Images were taken pre-injection and post-injection
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Types of Artifacts on a Segment Basis by Blinded Reader 3
大体时间:Images were taken pre-injection and post-injection
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The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
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Images were taken pre-injection and post-injection
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The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
大体时间:Images were taken pre-injection and post-injection
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Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.
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Images were taken pre-injection and post-injection
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Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
大体时间:Images were taken pre-injection and post-injection
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The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%.
If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated.
If there was no stenosis of >=70% in a segment then the length was designated as 0.
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Images were taken pre-injection and post-injection
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The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
大体时间:Images were taken pre-injection and post-injection
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Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease.
The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus.
Each of the three parameters were assessed as present or absent in the region distal to the stenosis.
If they were found in any segment distal to the stenosis then they were assessed as present.
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Images were taken pre-injection and post-injection
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Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
大体时间:Images were taken pre-injection and post-injection
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Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease.
The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus.
Each of the three parameters were assessed as present or absent in the region distal to the stenosis.
If they were found in any segment distal to the stenosis then they were assessed as present.
If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.
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Images were taken pre-injection and post-injection
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Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
大体时间:Images were taken pre-injection and post-injection
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Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment.
This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment.
The degree of confidence was rated on a 4-point scale: 1 = Not confident, 2 = Somewhat confident, 3 = Confident, and 4 = Very confident.
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Images were taken pre-injection and post-injection
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The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
大体时间:Images were taken pre-injection and post-injection
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A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered.
The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.
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Images were taken pre-injection and post-injection
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Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1
大体时间:Images were taken pre-injection and post-injection
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An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
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Images were taken pre-injection and post-injection
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Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2
大体时间:Images were taken pre-injection and post-injection
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An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
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Images were taken pre-injection and post-injection
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Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3
大体时间:Images were taken pre-injection and post-injection
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An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
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Images were taken pre-injection and post-injection
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合作者和调查者
赞助
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 14607
- 2010-023001-36 (EudraCT编号)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Gadobutrol (Gadovist, BAY86-4875)的临床试验
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Bayer完全的冠状动脉疾病新西兰, 英国, 美国, 法国, 德国, 大韩民国, 瑞士