跳至主要内容
临床试验/NCT07620925
NCT07620925招募中不适用

Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study

Azienda Ospedaliera "Sant'Andrea"5 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
5

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 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.

排除标准

  • 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).

研究者

发起方
Azienda Ospedaliera "Sant'Andrea"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emanuele Barbato

Full Professor

Azienda Ospedaliera "Sant'Andrea"

研究点 (5)

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