NCT05964452终止不适用
The Efficacy of Cook County Health's Methimazole Dosing Algorithm in the Setting of Ne Onset Graves' Hyperthyroidism
Cook County Health1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Achievement of euthyroid state
研究概览
简要总结
To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves' disease.
详细描述
To conduct a prospective observational study in 60 patients with newly diagnosed Graves' disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm and assess for efficacy and safety of MMI dosing administered. Study group size is based on 90% power and projected efficacy of 70% patients reaching target.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Non-pregnant adults (>18 years of age) with new diagnosis of Graves' Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and
- •either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm.
排除标准
- •Pregnant patients
- •hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc.
- •Graves patients who present with atrial fibrillation, CHF or other end organ damage
结局指标
主要结局
Achievement of euthyroid state
时间窗: 17 weeks
The proportion of patients achieving euthyroid state during the study period
次要结局
- Factors influencing achievement of euthyroid state(17 weeks)
研究者
Dan Mihailescu
MD Endocrinology Cluster Director
Cook County Health
研究点 (1)
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