Hypothyroidism After the TAVI Procedure in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To assess the underlying thyroid disease
研究概览
简要总结
Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment.
详细描述
Aortic stenosis is highly prevalent in advancing age. The prevalence is 2.5% at an age of 75 years and 8.1% at an age of 85 years. The estimated mortality after onset of symptoms (dizziness, syncope, thoracic pain and dyspnea) with conventional medical treatment is 75% after 3 years follow up. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve. However, an open surgical procedure is not always possible in high risk patients for anatomical reasons (sternotomy, radiation and chest deformation) or comorbidities defined by the Euroscore and the Society of Thoracic Surgeons' risk score (STS score).
Trans-catheter aortic valve replacement (TAVI) is becoming the standard care of patients suffering of non-operable, high risk severe and symptomatic aortic stenosis. The TAVI procedure is associated with immediate hemodynamic improvement characterized by a decreased aortic valve mean pressure gradient, an improved left ventricular end systolic volume and mass, a decreased end ventricular diastolic volume and a better ejection fraction. This hemodynamic improvement translates into better clinical outcomes. Mortality rates (2.2% and 6.7% at one month and at one year) and long term stroke rate are similar after TAVI or surgical replacement.
The TAVI procedure is also successful in octogenarian and in frail patients. Consequently, patient's frailty is a growing argument to refer the patient for a percutaneous treatment of valve disease instead of a conventional surgical approach.
The standard evaluation before the TAVI procedure comprises some radiologic studies with iodinated contrast agent (coronarography, thoracic CT scanner and the TAVI procedure itself). Furthermore, some patients require a treatment with Amiodarone® because of the occurrence of atrial fibrillation during the procedure.
A typical iodinated contrast study confers 13500 µg of free iodine and 15-60g of bound iodine (several hundred thousand times above the recommended daily intake). An excess of iodium expo-sure can lead to thyroid dysfunction:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated, written Informed Consent prior to any study specific proce-dures
- •Patient: males and females must be ≥ 70 years old
- •Patients who will undergo a TAVI procedure
排除标准
- •- No obtained signed, dated and written Informed Consent.
- •Known thyroid dysfunction (for example: Basedow, Hashimoto,...)
- •Patients receiving any of the following: Lithium, Strumazol or a recent treatment of radio-Iode
结局指标
主要结局
To assess the underlying thyroid disease
时间窗: At baseline
Presence of thyroid nodule door ultra sound
to assess prospectively the incidence of hypothyroidism after a TAVI procedure.
时间窗: Baseline, at 4-8-12 weeks
Change is value of TSH and fT4,
To assess the influence of iodinated constrast on hypothyroidism
时间窗: At 4 weeks
Value of presence of Iodine in urine sample
To assess the influence of autoimmune disease on hypothyroidism after TAVI
时间窗: Baseline
Anti TPO
To assess the influence of presence of antibodies on hypothyroidism after TAVI
时间窗: Baseline
Anti TG
次要结局
- to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on dependence level(Baseline and at 1 month)
- to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on depression(Baseline and at 1 month)
- to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on instrumental daily living(Baseline and at 1 month)
- to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on the cognitive function(Baseline and at 1 month)
- to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on mobility(Baseline and at 1 month)
研究者
Nathalie compté
Clinic head of geriatric unit
Universitair Ziekenhuis Brussel