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Идёт набор NCT03910569

The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study

— Наблюдательное Takotsubo Cardiomyopathy

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Takotsubo Cardiomyopathy. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Smidt Heart Institute Takotsubo Registry

Обзор

The Cedars-Sinai SHI Takotsubo Registry and Proteomic Study is an observational registry that will collect retrospective and prospective demographic, clinical, hemodynamic, laboratory and other diagnostic parameters, therapy and outcome data from individuals who meet the inclusion/exclusion criteria of Takotsubo Registry protocol. Subjects will also be invited to provide a blood sample utilizing a Mitra kit sent to their homes. Researchers from the Barbra Streisand Women's Heart Center will analyze Registry data to identify Takotsubo phenotypes, improve diagnostic capabilities, better predict recurrence rates, and develop targeted Takotsubo treatments.

Подробное описание

Registry outreach will begin with an informational and inspirational website and will utilize social media and patient-driven activism through Facebook, blogs and Twitter modalities that have demonstrated efficiencies in other patient-centered research efforts. Subjects will upload specific clinical materials into Cedar-Sinai's web-enabled cloud storage and which will be screened by trained Smidt Heart Institute physicians. The Registry utilizes on-line, e-consent and enrollment connected to a REDCap database that will allow efficient data input for analysis. All potential subjects who have been diagnosed with Takotsubo or have been informed by their physician that they meet diagnosis criteria, will need to provide information for review that includes: hospitalization records, from the time of Takotsubo event, with laboratory data (particularly -- troponin level), ECG and CTA. Registrants will be asked to respond to annual update surveys.

The goal is to accurately understand the prevalence, recurrence and prospective status of the Takotsubo, to determine which individuals are at risk of reoccurrence or subsequent adverse event and to determine potential treatment targets to develop therapeutic strategies

Primary:

* To establish a large USA-based database for patients with Takotsubo with a convenient and easy to use on-line patient-advocate registry using digital media marketing, Box cloud data access and storage, accurate case adjudication, and automated follow-up. * Participants will also be offered the option of participating in the Takotsubo Proteomic Registry by providing remote ambulatory Mitra blood samples.

Secondary:

• To establish a clinical trial platform for patient-centered point-of-care trials to improve diagnostics, clinical care and outcomes.

Первичные конечные точки

  • Number of participants with Prevalence of the Takotsubo [Срок оценки: Baseline, Annual follow-up up to 30years]
  • Number of participants with Recurrence the Takotsubo [Срок оценки: Baseline, Annual follow-up up to 30years]
  • Annual update surveys will collect data on patient's prospective health status following Takotsubo event [Срок оценки: Baseline, Annual follow-up up to 30years]
  • Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event [Срок оценки: Baseline, Annual follow-up up to 30years]

Критерии участия

Критерии включения

  • Have received a diagnosis of Takotsubo from their physician and consent to enroll
  • Submit full medical records needed for Takotsubo adjudication

Критерии исключения

  • Younger than 18 years
  • Unable to provide informed consent
  • Unable to provide the necessary documentation needed for screening purposes

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Cedars Sinai Medical Center — Los Angeles

Публикации

  • Marano P, Maughan J, Obrutu O, Lauzon M, Tjoe B, Herscovici R, Moy P, Rojas N, Shufelt C, Rutledge T, Wei J, Bairey Merz CN. Evaluation of Recurrent Takotsubo Syndrome. JACC Adv. 2024 Sep 17;3(10):101247. doi: 10.1016/j.jacadv.2024.101247. eCollection 2024 Oct. PMID 39324115

Идентификаторы

NCT: NCT03910569 · 53569

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗