Post Thyroidectomy Myocardial Function
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Echocardiographic Assessment of Changes in Myocardial Function at 3, 6 and 12 months after Thyroidectomy
研究概览
简要总结
Protocol Synopsis
Protocol title: Post thyroidectomy myocardial function Purpose: Evaluation of the effects of total thyroidectomy on myocardial function Design: Prospective, single-center, cohort study Patient Population: Male or female subjects 18 years of age or older who are scheduled for total thyroidectomy No. of Subjects: 50 patients, estimated up to 12 months to enroll Duration of Treatment: Operation Duration of Follow-up: After discharge, the patients will be re-evaluated at three (3), six (6) and twelve (12) months in the outpatient clinic.
Endpoints: To evaluate the changes in the myocardial function after the removal of the thyroid gland.
详细描述
1.0 INTRODUCTION
It is commonly known that the thyroid hormones affect the function of the cardiovascular system. Several studies mention that these hormones influence the cardiac function and geometry directly and indirectly. Three potential mechanisms have been described, which are the direct cellular effect, the interaction with the sympathetic nervous system and changes in peripheral circulation.
A few studies have been already published , dealing with the correlation between thyroid hormones and heart function. Only one of them have proved a suppressed ventricular contractility after subtotal thyroidectomy for hyperthyroidism.
This clinical trial aims to compare the pre- and post-operative heart function after total thyroidectomy, using echocardiography. Outcomes will be assessed during patient hospitalization and at three, six and twelve months' follow-up appointments.
2.0 OBJECTIVES
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
- 是
入选标准
- •Patient is over 18 years old
- •Patient scheduled for a non-emergency operation
- •Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
- •No previous cardiologic history
- •Normal PTH values (no transient hypoparathyroidism)
排除标准
- •Patient is underage ( under 18 years old)
- •Patient had a previous operation at the thyroid or parathyroids
- •Patient inability to participate in follow-up appointments
- •Patient is participating in another clinical trial which may affect this study's outcomes
- •Patient with TSH values outside the range of normal values
- •Pathologic Ca2+ , Vit D, P, PTH, pre- and post-operative values
- •Diabetes Mellitus, Hypertension, History of any heart, lung or systemic disease.
结局指标
主要结局
Echocardiographic Assessment of Changes in Myocardial Function at 3, 6 and 12 months after Thyroidectomy
时间窗: They will be assessed at 3, 6 and 12 months after thyroidectomy.
次要结局
未报告次要终点
研究者
Papavramidis Theodossis
Assistant Professor of Surgery, Aristotle University of Thessaloniki
Aristotle University Of Thessaloniki