跳至主要内容
临床试验/NCT03910569
NCT03910569招募中不适用

Smidt Heart Institute Takotsubo Registry

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Number of participants with Prevalence of the Takotsubo

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Number of participants with Prevalence of the Takotsubo

时间窗: Baseline, Annual follow-up up to 30years

Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.

Number of participants with Recurrence the Takotsubo

时间窗: Baseline, Annual follow-up up to 30years

Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed.

Annual update surveys will collect data on patient's prospective health status following Takotsubo event

时间窗: Baseline, Annual follow-up up to 30years

Prospective statusof the Takotsubo will be measured annually. Change from baseline will be assessed.

Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event

时间窗: Baseline, Annual follow-up up to 30years

Risk factors for reoccurrence or subsequent adverse event will be collected annually.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noel Bairey Merz

Director of Women's Heart Center

Cedars-Sinai Medical Center

研究点 (2)

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