此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Global Initiative on Takayasu Arteritis (GITA) (GITA)

2026年4月23日更新者：Fatma Alibaz Oner、Marmara University

Takayasu's Arteritis Global Registry

Takayasu's Arteritis Global Registry aims to bring a large group of patients from different parts of the world to analyse and compare the patients' demographic, clinical, laboratory, radiological and prognostic features with outcomes, approaches to diagnosis, assessment, management and therapeutic interventions in different centers. The present project provides for both a retrospective and a prospective longitudinal study. The study is designed as retrospective for patients already diagnosed with TAK and treated with available treatments. Also, the study is designed as prospective for patients diagnosed with TAK after the initiation of the Registry or the adhesion to the project. This is thought as a multicentre, international study addressed to all Centers that will want to contribute to the present project. The study is non-interventional: demographic, clinical and therapeutic data required over time are collected with the routine diagnostic, clinical and therapeutic procedures usually carried out for the optimal management of patients and according with good clinical practice.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Fatma Alibaz-Oner, Professor, MD
电话号码：+902166574545
邮箱：falibaz@gmail.com

学习地点

土耳其（türkiye）
- Istanbul
  - Istanbul、Istanbul、土耳其（türkiye）、34899
    - 招聘中
    - Marmara University School of medicine
    - 接触：
      
      Fatma Alibaz Oner, Professor, MD
      
      电话号码：+902166574545
      
      邮箱：falibaz@gmail.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients aged >18 years diagnosed with Takayasu arteritis according to ACR 1990 or ACR/EULAR 2021 criteria will be included

描述

Inclusion Criteria:

Each patient must fullfill the ACR 1990 or ACR/EULAR 2021 criteria for Takayasu arteritis.
Patients (or legally acceptable representatives of subjects enrolled) have to
provide informed and free agreement to participate in the study and to disclose any medical event to the investigator. The parents or legally acceptable representative and the adolescent subject must be willing and able to comply with the study protocol requirements for the duration of the study
freely sign written and dated informed consent after being duly informed of the nature, significance, and implications of the study;
be informed that the patient enrolled may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

Patients must be excluded from the study when the following criteria are observed:

The patient does not full-fill the ACR 1990 or ACR/EULAR 2021 criteria for Takayasu arteritis
informed consent/assent is not provided and signed

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Takayasu's arteritis This prospective observational, multi-centre, multi-national cohort study aims to comprehensively collect and analyse the demographic, clinical, laboratory, and radiological data of patients with TAK. By doing so, the TAK Registry will enable the investigation of key outcomes, including disease activity, relapse and mortality and associated factors, ultimately contributing to a better understanding and management of TAK.

团体/队列

Takayasu's arteritis

This prospective observational, multi-centre, multi-national cohort study aims to comprehensively collect and analyse the demographic, clinical, laboratory, and radiological data of patients with TAK. By doing so, the TAK Registry will enable the investigation of key outcomes, including disease activity, relapse and mortality and associated factors, ultimately contributing to a better understanding and management of TAK.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Rate of Clinical Remission at 12 Months 大体时间：120th month from the start of the study	Clinical remission will be defined according to the absence of clinical signs and symptoms of active disease and normalization of inflammatory markers	120th month from the start of the study

次要结果测量

结果测量	措施说明	大体时间
Incidence of Disease Relapse During Follow-up 大体时间：From baseline through study completion (up to 120 months)	Number of events per patient-year	From baseline through study completion (up to 120 months)
Frequency of Long-term Complications During Follow-up 大体时间：120 months	Percentage of patients who experience complications	120 months
Change in damage during follow-up 大体时间：From baseline through study completion (up to 120 months)	Change in damage assessed with LVVID and TADS scores	From baseline through study completion (up to 120 months)
Rate of radiographic progression 大体时间：From baseline through study completion (up to 120 months)	New lesion or progression of existing vascular lesion in BTA, MRA or new or increased active vasculitic uptake in vascular territory with PET/CT	From baseline through study completion (up to 120 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Marmara University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月5日

初级完成 (估计的)

2035年8月1日

研究完成 (估计的)

2035年8月1日

研究注册日期

首次提交

2026年4月9日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)