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临床试验/NCT01490294
NCT01490294已完成2 期

Multicenter, Double Blind, Randomized Dose Finding Study in Myocardial Perfusion MRI With Gadavist®1.0

Bayer0 个研究点目标入组 232 人开始时间: 2004年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Bayer
入组人数
232
主要终点
Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality.

For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min.

The total imaging time is about 45 min.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
  • •The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

排除标准

  • •Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
  • •Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
  • •Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
  • •Non-sinus rhythm
  • •Sinus node disease or symptomatic bradycardia
  • •Second or third degree atrial ventricular (AV) block
  • •Complete left bundle branch block (LBBB)
  • •Known congenital long QT syndrome or a family history of congenital long QT syndrome
  • •Known previous arrhythmias on drugs that prolong cardiac repolarization
  • •Uncorrected hypokalemia
  • •Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
  • •Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
  • •Ejection fraction below 35%
  • •Cardiomyopathy, congenital heart defect or higher degree valvular pathology
  • •Coronary artery stent placement within 4 weeks prior to the MRI procedure
  • •Previous heart transplantation

研究组 & 干预措施

Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

干预措施: Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Drug)

Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

干预措施: Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Drug)

Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

干预措施: Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Drug)

Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)

Experimental

Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

干预措施: Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Drug)

结局指标

主要结局

Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions

时间窗: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.

Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments

时间窗: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

次要结局

  • Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Signal Intensity (SIrel) Based on Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI) " (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Upslope Based on Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Time to Peak Based on Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes)
  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions(Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration)
  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments(Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration)
  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions(Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration)
  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments(Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)(Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration)
  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration)
  • Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)(Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration)
  • Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions(Immediately within approximately 5 seconds after Gadobutrol bolus administration)
  • Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)(Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration)
  • Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)(Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration)
  • Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)(Immediately within approximately 5 seconds after Gadobutrol bolus administration)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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