Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
Molecular Imaging and Deep Phenotyping to Identify Predictors of AS Disease Activity and Progression
研究概览
详细说明
Structural imaging modalities, such as echocardiography (echo) and computed tomography (CT), measure the structural consequences of aortic valvular calcification and have proven invaluable for grading AS severity. However, these techniques cannot capture the dynamic microcalcification processes that drive the underlying disease and have proven insufficient for predicting AS progression. In contrast, molecular imaging with 18F-NaF positron emission tomography/computed tomography (18F-NaF PET/CT) is the gold-standard method for noninvasively measuring the central pathophysiological process driving the progression of AS. This imaging approach uses 18F-sodium fluoride, a tracer that binds preferentially to hydroxyapatite in regions of developing microcalcification. This enables quantification of microcalcification activity (which precedes visible macrocalcification) and provides insights into the underlying disease activity that drives AS progression. Notably, optimized protocols for 18F-NaF PET/CT yield a reproducible biomarker to track disease activity and predict progression. Furthermore, recent advances in PET technology (such as total-body PET scanners) have improved sensitivity by 10- to 40-fold, further enhancing the quantification of the microcalcification rate underlying AS progression.
Overall, the assessment of microcalcification activity shifts the focus from static anatomical assessments to measurement of the dynamic pathological process driving AS progression. However, while 18F-NaF PET/CT is unsuitable for routine clinical use (because it is costly and currently limited to research applications), it can be effectively leveraged to train predictive models and deploy them as clinical calculators to estimate the rate of microcalcification from readily available biomarker data. The resulting clinical models and calculators could greatly enhance clinical care by identifying patients at risk of rapid progression, refining risk stratification and prognostic accuracy, and opening avenues for personalized monitoring and treatment in calcific AS.
The overarching goal of this Clinical Imaging Study is to develop novel predictive models and clinical calculators that capture AS microcalcification activity and forecast the risk of progressive aortic valve stenosis among participants with mild-to-moderate AS. The investigators will achieve this by performing advanced multimodality imaging, including 18F-NaF PET/CT, to quantify microcalcification activity in deeply phenotyped patients using clinical, imaging, and blood plasma biomarkers. Computational approaches, including AI tools, will identify optimal combinations of imaging and non-imaging predictors of microcalcification activity. The investigators will then develop accessible clinical calculators and test the hypothesis that these models and calculators enhance identification of rapid progressors through cross-validation and external validation in the Population Project cohort (which undergoes identical biomarker phenotyping).
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Ahmed Tawakol A Director, MD
- 电话号码:3699 6177262000
- 邮箱:atawakol@mgh.harvard.edu
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Males and females
- aged 18 years or older
- mild to moderate calcific Aortic Stenosis (as defined by standard echocardiographic criteria)
Exclusion Criteria:
- Bicuspid Aortic Stenosis
- pregnancy
- cognitive disabilities that impair the ability to comply with instructions or provide informed consent
- any other medical condition that may undermine participation
- weight >300 lbs
- severe claustrophobia
- Pregnancy
- subjects who have had significant radiation exposure as part of research (>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12 months
- Individuals with renal dysfunction (eGFR<55) or a history of allergic reaction to iodinated contrast will not receive the iodinated contrast.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
Individuals with mild or moderate aortic stenosis
Mild or moderate aortic stenosis noted on imaging and not expected to undergo treatment of the aortic valve over the next year.
|
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 |
|---|---|---|
|
rate of AS progression
大体时间:One year
|
change of echo- and CT-derived AS measures
|
One year
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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
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