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Идёт набор NCT04281823

DeBakey Cardiovascular Magnetic Resonance Study

— Наблюдательное Cardiovascular Diseases

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: Cardiovascular Magnetic Resonance.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases. Базовые параметры: Без ограничений · 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 →

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Официальное название

Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

Обзор

While advancements in cardiac magnetic resonance (CMR) have improved image quality, it is unclear how these improvements are connected to the clinical evaluation of individuals with cardiovascular disease. The aim of this large prospective registry revolves around 4 key principles: 1) utilize CMR to gain additional pathophysiologic insights into cardiovascular disease, 2) understand how CMR compares to alternative cardiovascular diagnostic modalities, 3) determine how CMR affects clinical management decisions, and 4) establish a link between CMR findings and long term prognosis in patients with known or suspected cardiovascular disease. The ultimate aim is to utilize CMR to improve patient outcomes. CMR techniques to be studies include function, fibrosis, and flow. Focus areas include valvular heart disease, ischemic heart disease, cardiomyopathies, and vascular disease.

Подробное описание

Patient Population, Recruitment, and Consent:

Patients presenting to the Houston Methodist DeBakey CMR Laboratory will be enrolled from April 2008 to April 2038. It is expected that up to 100,000 patients may be enrolled during this period.

Subjects will be identified based on their referral to the Houston Methodist DeBakey CMR Laboratory for MRI studies during the proposed study period.

After enrollment, a registered nurse or physician will perform a thorough structured patient interview and/or review of electronic health records to document baseline medical history including cardiac risk factors, symptoms, medication usage, and prior procedure history. A small blood sample will be drawn and stored for future biomarker and/or genetic testing analysis. Annual follow up for clinical status will be performed via review of electronic health records; structured telephone interviews with the patients, relatives, and/or their health care providers; and/or the social security death index database.

Вмешательства

  • Диагностический тест Cardiovascular Magnetic Resonance
    Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.

Первичные конечные точки

  • Mortality [Срок оценки: Through study completion, an average of once a year, up to 20 years]
  • Heart Failure [Срок оценки: Through study completion, an average of once a year, up to 20 years]
  • Heart and/or Lung Transplantation [Срок оценки: Through study completion, an average of once a year, up to 20 years]
  • Left Ventricular and/or Right Ventricular Assist Device Implantation [Срок оценки: Through study completion, an average of once a year, up to 20 years]
Вторичные конечные точки (4)
  • Cardiac Interventions [Срок оценки: Through study completion, an average of once a year, up to 20 years]
  • Arrhythmic [Срок оценки: Through study completion, an average of once a year]
  • Acute myocardial infarction [Срок оценки: Through study completion, an average of once a year, up to 20 years]
  • Acute Cerebrovascular Accident [Срок оценки: Through study completion, an average of once a year, up to 20 years]

Критерии участия

Критерии включения

  • All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.

Критерии исключения

  • Unable to provide informed consent

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Houston Methodist Hospital — Houston

Публикации

  • Malahfji M, Bhugra P, Nguyen DT, Crudo V, Saeed M, Reardon M, Nagueh SF, Zoghbi WA, Graviss EA, Shah DJ. Cardiac MRI Evaluation of Determinants and Prognostic Implications of Right Ventricular Dysfunction in Aortic Regurgitation. Radiol Cardiothorac Imaging. 2025 Feb;7(1):e230389. doi: 10.1148/ryct.230389. PMID 39745324
  • Tayal B, Faza NN, Nguyen DT, Malahfji M, Little S, Saeed M, Goel SS, Guha A, El-Tallawi KC, Graviss EA, Shah DJ. Association of secondary mitral regurgitation and right ventricular dysfunction among patients with non-ischaemic cardiomyopathy. Eur Heart J Cardiovasc Imaging. 2024 Nov 27;25(12):1627-1635. doi: 10.1093/ehjci/jeae134. PMID 38781428
  • Tayal B, Debs D, Nabi F, Malahfji M, Little SH, Reardon M, Zoghbi W, Kleiman N, Shah DJ. Impact of Myocardial Scar on Prognostic Implication of Secondary Mitral Regurgitation in Heart Failure. JACC Cardiovasc Imaging. 2021 Apr;14(4):812-822. doi: 10.1016/j.jcmg.2020.11.004. Epub 2020 Dec 16. PMID 33341417
  • Kitkungvan D, Yang EY, El Tallawi KC, Nagueh SF, Nabi F, Khan MA, Nguyen DT, Graviss EA, Lawrie GM, Zoghbi WA, Bonow RO, Quinones MA, Shah DJ. Extracellular Volume in Primary Mitral Regurgitation. JACC Cardiovasc Imaging. 2021 Jun;14(6):1146-1160. doi: 10.1016/j.jcmg.2020.10.010. Epub 2020 Dec 16. PMID 33341409

Идентификаторы

NCT: NCT04281823 · Pro00008766

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗