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Идёт набор NCT06780241

Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

Наблюдательное Aortic Regurgitation Mitral Regurgitation 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: CMR, Quality of Life Questionnaire.
Кому может быть актуально
Состояния в реестре: Aortic Regurgitation, Mitral Regurgitation, Aortic Stenosis. Базовые параметры: 18 лет — 90 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping. The aim to use standard and advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is to determine advanced CMR predictors of reverse remodeling following aortic valve surgery and develop sex-specific thresholds for risk. Infrastructure developed by this study will enable development of an innovative, scalable, sex-specific precision medicine cardiovascular imaging pipeline to determine overall risk and treatment response.

Подробное описание

Chronic valvular heart disease leads to significant left ventricular (LV) remodeling. Current national guidelines for surgical/procedural referral for valvular heart disease do not consider sex differences in presence of symptoms, LV remodeling and dysfunction. However, our prior research in patients with chronic aortic regurgitation, validated by our recent multicenter study, demonstrated that despite higher left ventricular function, and less ventricular dilation, females experienced more heart failure symptoms, fewer referrals for surgical intervention, and higher prevalence of adverse outcomes compared to males. Similarly, published HVTI data have demonstrated increased adverse outcomes in women referred for surgical mitral valve intervention.

Cardiac magnetic resonance (CMR) provides an exciting opportunity to characterize sex differences in LV remodeling.In combination with conventional CMR measures, novel CMR techniques such as Magnetic Resonance Fingerprinting (MRF), Diffusion Tensor imaging (DTI) and radiomics analysis provide tissue level specificity with potential to enhance phenomapping.

Limitations in understanding sex-specific remodeling patterns stem from heterogeneity of presentation, which confound traditional analytic methods. Phenomapping, a method of machine learning, clusters imaging features and patients into distinct phenotypic groups. Unsupervised phenomapping enables unbiased grouping of patients by both clinical characteristics as well as complex imaging features. In recent studies, this unbiased phenomapping approach demonstrates superior risk stratification of cardiac disease compared to traditional approaches that can be used to guide individualized treatment

The aim to use advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is to determine advanced CMR predictors of reverse remodeling following procedural valve intervention and develop sex-specific thresholds for risk. Results from this study would enable the development of sex-specific precision medicine pathway, augmented by advanced imaging features, to better predict overall risk and treatment response, and thus enable novel patient selection criteria.

Study hypothesis: Radiomics, MRF, chemical exchange transfer, and DTI will elucidate distinct sex-specific biologic signatures, in addition to standard CMR imaging features, and are associated with adverse outcomes, and reverse remodeling following surgical/procedural valve intervention.

Вмешательства

  • Диагностический тест CMR
    CMR (with contrast at baseline and non-contrast at follow-up)
  • Другое Quality of Life Questionnaire
    Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire

Первичные конечные точки

  • Change in LV Dilation and/or change in LVEF [Срок оценки: 6-12 months]
Вторичные конечные точки (4)
  • Change in Aortic Regurgiation [Срок оценки: 6-12 months]
  • Change in BNP [Срок оценки: 6-12 months]
  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score [Срок оценки: 6-12 months]
  • 6 minute walk test [Срок оценки: 6-12 months]

Критерии участия

Критерии включения

  • Age 18-90 years of age
  • Suspected moderate or severe (2-3+ or more) aortic regurgitation, or moderate or more aortic stenosis on the basis of prior known clinical history, echocardiogram or cardiac MRI.

Критерии исключения

  • Acute traumatic cardiac injury
  • Aortic dissection or aortic root rupture
  • Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
  • Presence of A-V fistula or intracardiac shunts
  • Any contraindications to cardiac MRI including:
  • Patients with any MR-incompatible implant, including cardiac pacemakers or defibrillators, or older types of cerebral aneurysm clips.
  • Patients who weigh more than 440 lbs. or have a very wide waist circumference.
  • Patients with claustrophobia may have difficulty tolerating the exam.

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
  • Cleveland Clinic — Cleveland

Идентификаторы

NCT: NCT06780241 · 24-861

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗