Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study (Echo-AVCS)
2026年6月3日 更新者：Emanuele Barbato、Azienda Ospedaliera "Sant'Andrea"
The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS).
Transthoracic echocardiography (TTE) is the standard imaging modality for assessing AS severity; however, discrepancies between valve area and transvalvular gradient measurements may complicate diagnosis, particularly in low-flow or discordant AS presentations.
Cardiac computed tomography (CT)-derived aortic valve calcium scoring is currently used to resolve diagnostic uncertainty, but it involves additional cost and radiation exposure.
This study will enroll consecutive adult patients undergoing clinically indicated TTE and cardiac CT with calcium scoring performed within 3 months.
Standardized echocardiographic images will be centrally analyzed using dedicated AI-based image segmentation and machine learning methods to quantify aortic valve calcification directly from TTE images.
CT-derived aortic valve calcium score will serve as the reference standard.
The primary objective is to derive and validate the Echo-AVCS score for identifying severe AS.
Secondary objectives include determination of sex-specific diagnostic thresholds, correlation with CT calcium volume, association with symptoms and NYHA class, and evaluation of prognostic associations with aortic valve replacement, heart failure hospitalization, cardiovascular events, and mortality at 1-year follow-up.
研究概览
研究类型
观察性的
注册 (估计的)
250
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Emanuele Barbato, Full Professor
- 电话号码：0633778763
- 邮箱：emanuele.barbato@uniroma1.it
学习地点
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Bologna、意大利
- 招聘中
- University of Bologna
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接触：
- Carmine Pizzi
- 邮箱：carmine.pizzi@unibo.it
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副研究员：
- Luca Bergamaschi
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副研究员：
- Matteo Armillotta
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副研究员：
- Francesco Angeli
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Milan、意大利
- 招聘中
- Centro Cardiologico Monzino
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接触：
- Gianluca Pontone
- 电话号码：02 58002574
- 邮箱：gianluca.pontone@cardiologicomonzino.it
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副研究员：
- Saima Mushtaq, MD, PhD
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副研究员：
- Maria Elisabetta Mancini, MD
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Milan、意大利
- 招聘中
- IRCCS Galeazzi-Sant'Amborgio
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接触：
- Edoardo Conte
- 邮箱：edoardo.conte86@gmail.com
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副研究员：
- Tommaso Viva
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副研究员：
- Davide Marchetti
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Milan、意大利
- 主动，不招人
- Politecnico di Milano
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Roma、意大利
- 招聘中
- Sant'Andrea University Hospital
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副研究员：
- Pasquale Paolisso, MD, PhD
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副研究员：
- Marta Belmonte, MD, PhD
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接触：
- Emanuele Barbato, Full Professor
- 电话号码：0633778763
- 邮箱：emanuele.barbato@uniroma1.it
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接触：
- Pasquale Paolisso, MD, PhD
- 邮箱：pasquale.paolisso@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
The Echo-CA score Study is an investigator-initiated, prospective, multicenter study of consecutive patients undergoing clinically indicated standard transthoracic echocardiography and cardiac CT with available calcium score performed within 3 months.
The study population is expected to include approximately 50% patients with severe AS and 50% without severe AS, in order to ensure a balanced case-control distribution and optimize the precision of diagnostic performance estimates.
All patients will be managed according to current standards of care.
Clinical evaluation will include systematic collection of cardiovascular risk factors, comorbidities, medical therapy, and detailed symptom assessment (angina, syncope, dyspnea), as well as NYHA functional class.
Each participant will undergo: i) comprehensive transthoracic echocardiography (TTE) performed according to current ESC Guideline; ii) cardiac CT with aortic valve calcium quantification, performed according to contemporary acquisiti
描述
Inclusion Criteria:
- Age > 18 years old
- Clinical indication for standard transthoracic echocardiography.
- Clinical indication for cardiac CT with available calcium score.
- 3-month time interval between transthoracic echocardiography and cardiac CT.
- Able to give informed consent.
Exclusion Criteria:
- Patients with inadequate transthoracic echocardiographic images.
- Poor quality cardiac CT, inadequate for standard calcium score assessment.
- Patients with known prior stents and/or coronary artery bypass grafts.
- Patients with known previous percutaneous or surgical aortic valve replacement.
- Patients with active or a history of endocarditis.
- Patients with congenital heart defects (other than isolated bicuspid aortic valve).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Patients undergoing transthoracic echocardiography and cardiac-CT with available calcium score
Consecutive patients undergoing clinically indicated standard transthoracic echocardiography and cardiac CT with available calcium score performed within 3 months
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This is a non-interventional, observational study in which all patients will undergo clinically indicated standard-of-care transthoracic echocardiography (TTE) and cardiac computed tomography (CT) with aortic valve calcium scoring.
No investigational drug, device, or additional invasive procedure will be administered as part of the study.
Echocardiographic images acquired during routine clinical practice will be anonymized and centrally analyzed using dedicated artificial intelligence-based software to derive and validate the echocardiographic aortic valve calcium score.
Patient management, follow-up, and therapeutic decisions, including referral for aortic valve replacement, will remain entirely at the discretion of the treating physicians according to current clinical guidelines and standard practice.
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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 |
|---|---|---|
|
Derivation of Echo-AVCS
大体时间：6 months
|
To derive an echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS), using CT-derived aortic valve calcium as the reference standard.
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6 months
|
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Validation of Echo-AVCS
大体时间：6 months
|
To validate an echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS), using CT-derived aortic valve calcium as the reference standard.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sex-specific thresholds
大体时间：6 months
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To determine sex-specific thresholds (male vs. female) for the echocardiographic aortic valve calcium score (Echo-AVCS).
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6 months
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Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³)
大体时间：6 months
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To assess the correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) measured by cardiac computed tomography.
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6 months
|
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Correlation of the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms
大体时间：1-year
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To correlate the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms (angina, syncope, and dyspnea).
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1-year
|
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Association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR)
大体时间：1 year
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To evaluate the association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR) according to current ESC Guidelines.
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1 year
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Correlation of the echocardiographic aortic valve calcium score with the patient's NYHA Class.
大体时间：1 year
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To correlate the echocardiographic aortic valve calcium score with the patient's NYHA Class.
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1 year
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Correlation of the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up.
大体时间：1 year
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To correlate the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up.
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1 year
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Correlation of the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up.
大体时间：1 year
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To correlate the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up.
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1 year
|
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Correlation of the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up.
大体时间：1 year
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To correlate the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up.
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1 year
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Correlation of the echocardiographic aortic valve calcium score with major adverse cardiovascular events (cardiovascular death and hospitalization for heart failure) at 1-year follow-up.
大体时间：1 year
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To correlate the echocardiographic aortic valve calcium score with major adverse cardiovascular events (cardiovascular death and hospitalization for heart failure) at 1-year follow-up.
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月1日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年5月27日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年6月3日
最后验证
2026年5月1日
更多信息
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.