Molecular MRI of the Fibrotic Heart
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Arm 1 - Validation of gadolinium free fibrosis imaging against current standard of care LGE-CMR
研究概览
简要总结
This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients. Participants will not receive a study drug or placebo and will not be randomized. A total of 250 participants will be enrolled into this study.
详细描述
This study had two treatment arms.
Arm 1: Participants will be enrolled in this arm if they have been referred to the Gill Heart Institute MRI center for diagnostic late gadolinium enhancement (LGE) -CMR imaging of fibrosis, or if they are a healthy volunteer.
If a participant is a Gill Heart Institute referral patient , they will receive an intravenous (through a vein in the arm) infusion of gadolinium as part of their clinical examination. Participants will also have electrocardiogram (ECG) waveform performed in order to gate the MRI scan. The MRI scan of the heart, for which the participant has been referred will last approximately 1 hour. Participants will have an additional 5-10 minutes of scans performed, none of which require additional infusions.
If the participant is a healthy volunteer, they will have an ECG waveform performed in order to gate your MRI scan, and they will have approximately 30-45 minutes of scanning performed on their heart. Participants will not receive an infusion of gadolinium.
Arm 2: Only participants who are already participating in a study being conducted by Dr. Harmut Malluche at the University of Kentucky, Department of Nephrology or, if you are a healthy volunteer, will be enrolled into this arm.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants between the ages of 20 and 80
- •Diagnosis or suspicion of myocardial fibrosis
- •Referral for LGE-CMR
排除标准
- •Confirmed acute MI within the prior 72 hours
- •Unstable ECG or arrhythmia as determined by the referring physician
- •Inability to hold one's breath for at least 10 seconds
- •Standard MRI safety exclusion criteria
- •Allergic reaction to Gadolinium
- •Women who are pregnant, think they are pregnant or who breastfeeding
- •Inclusion Criteria:
- •Participants between the ages of 20 and 80
- •History of between 1-10 years of routine hemodialysis
- •Healthy Volunteers
- •Confirmed acute myocardial infarction within the prior 72 hours
- •Unstable ECG or arrhythmia
- •Inability to hold one's breath for at least 10 seconds
- •Standard MRI safety exclusion criteria
研究组 & 干预措施
Arm 1 Mycardial Fibrosis
MRI with Intravenous administration of gadolinium
干预措施: Arm 1 MRI with gadolinium (Drug)
结局指标
主要结局
Arm 1 - Validation of gadolinium free fibrosis imaging against current standard of care LGE-CMR
时间窗: 36 months
Results from this arm will focus on validating cine FI measured from MT-weighted bSSFP cine CMR against LGE-CMR and MOLLI characterization of fibrosis in patients referred to the Gill Heart Institute.
Arm 2 - Imaging of myocardial fibrosis in CKD patients
时间窗: 48 months
Will test the hypothesis that MT-weighted CMR can be applied to identify fibrotic remodeling in the hearts of CKD5 patients
次要结局
未报告次要终点
研究者
Moriel Vandsburger
Sponsor PI
University of Kentucky