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Идёт набор NCT07620925

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

— Наблюдательное Aortic Stenosis Chronic Coronary Syndrome Calcific Aortic Valve Disease Calcific Aortic Stenosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Echocardiography and Cardiac CT.
Кому может быть актуально
Состояния в реестре: Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease, Calcific Aortic Stenosis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Обзор

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.

Вмешательства

  • Диагностический тест Echocardiography and Cardiac CT
    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 soft

Первичные конечные точки

  • Derivation of Echo-AVCS [Срок оценки: 6 months]
  • Validation of Echo-AVCS [Срок оценки: 6 months]
Вторичные конечные точки (9)
  • Sex-specific thresholds [Срок оценки: 6 months]
  • Correlation between the echocardiographic aortic valve calcium score and the calcium volume (mm³) [Срок оценки: 6 months]
  • Correlation of the echocardiographic aortic valve calcium score and the presence and occurrence of patient symptoms [Срок оценки: 1-year]
  • Association between the echocardiographic aortic valve calcium score and the time to aortic valve replacement (AVR) [Срок оценки: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with the patient's NYHA Class. [Срок оценки: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with all-cause death at 1-year follow-up. [Срок оценки: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with cardiovascular death at 1-year follow-up. [Срок оценки: 1 year]
  • Correlation of the echocardiographic aortic valve calcium score with hospitalization for heart failure at 1-year follow-up. [Срок оценки: 1 year]
  • 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. [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 5 центров
  • University of Bologna — Bologna
  • Centro Cardiologico Monzino — Milan
  • IRCCS Galeazzi-Sant'Amborgio — Milan
  • Politecnico di Milano — Milan
  • Sant'Andrea University Hospital — Roma

Идентификаторы

NCT: NCT07620925 · 0335/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗