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Идёт набор NCT04645862

Prospective 4D CTA of BAV Competence

— Наблюдательное Bicuspid

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: CT scans.
Кому может быть актуально
Состояния в реестре: Bicuspid. 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
США
Следующий шаг
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Обзор

The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging protocol. There may also be patients enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not required for clinical care.

Подробное описание

The bicuspid aortic valve (BAV) is the most common congenital heart disease. The purpose of this study is to better understand the anatomy of physiologically normal, or competent, BAVs without stenosis or insufficiency (AI) in order to support evidence-based standardization of BAV repair surgery. Men and women over 18 years of age with a diagnosis of BAV and minimal aortic valve calcification at baseline will undergo annual 4D computed tomography angiography (CTA) scans, routine transthoracic echocardiograms, and history and physical assessments over the course of the 5-year study period. Patients who are pregnant, have renal insufficiency (creatinine 2 mg/dL), or who have a contraindication to intravenous contrast will be excluded. Patients will be stratified into study groups according to baseline AI: approximately half of patients will have no to mild AI at baseline and the other half will have moderate to severe AI at baseline. Anatomical measurements will be obtained from the 4D CTA scans and analyzed at each phase of the cardiac cycle, as well as longitudinally. The 4D CTA imaging and analysis will not impact medical care of the study participants; the anatomical measurements will be used in the future as evidence-based standards for determining valve repair candidacy for BAV patients with AI.

Вмешательства

  • Диагностический тест CT scans
    4D CTA imaging

Первичные конечные точки

  • Cusp surface areas over the cardiac cycle [Срок оценки: Through study completion, an average of 1 year]
  • Cusp height (geometric and effective) [Срок оценки: Through study completion, an average of 1 year]
  • Cusp free margin length [Срок оценки: Through study completion, an average of 1 year]
  • Cusp thickness (including raphe thickness, if applicable) [Срок оценки: Through study completion, an average of 1 year]
  • Commissural height [Срок оценки: Through study completion, an average of 1 year]
  • Sino tubular junction size [Срок оценки: Through study completion, an average of 1 year]
  • Size of the sinuses of Valsalva [Срок оценки: Through study completion, an average of 1 year]
  • Ventriculoaortic junction size [Срок оценки: Through study completion, an average of 1 year]
  • Aortic annulus size [Срок оценки: Through study completion, an average of 1 year]
  • Coaptation height at diastole [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (2)
  • Development of aortic insufficiency and/or stenosis. [Срок оценки: Through study completion, an average of 1 year]
  • Development of aortic insufficiency and/or stenosis. [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • At least 18 years of age
  • Documented bicuspid aortic valve identified via clinical imaging (e.g., CT, MRI, or echocardiogram) with minimal calcification at the time of enrollment
  • Participant must sign the informed consent form

Критерии исключения

  • Pregnancy (determined by point of care urine pregnancy test)
  • Renal failure (estimated Glomerular Filtration Rate (eGFR) < 30), precluding them from receiving intravenous contrast)
  • Documentation of previous intravenous contrast allergy (unless they are having a CT with steroid preparation as part of routine clinical care)
  • Previous aortic valve replacement

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT04645862 · 843190

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗