Triiodothyronine for repair of left ventricular dysfunction and Remodeling in STEMI Patients - The Thy-REPAIR study

ni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.0 个研究点目标入组 50 人开始时间: 2016年3月9日最近更新: 2021年12月6日

适应症

试验速览

暂无简介。

•Anterior or Anterolateral STEMI diagnosed according to ESC guidelines
•Referral to cardiac catheterization laboratory for Primary PCI with TIMI grade 2 or 3 flow
•Presentation within 12 hours of symptom onset (chest pain, chest discomfort)
•Male and female with Age >18 years old
•Signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Treatment with amiodarone at the time of admission
•Clinically significant chronic hepatic impairment (Child-Pugh Class B [moderate] or Class C [severe])
•Previous Acute Myocardial Infarction
•Previous history of Thyroid disease
•Treatment with T4, T3 or anti-thyroid drugs at the time of admission to hospital
•Renal failure (GFR<60ml/min)
•Acute cardiac decompensation requiring mechanical ventilation
•Patients holding mechanical cardiac valves, pacemakers, ICDs or infusion pumps, magnetic materials like metallic clips and prosthesis which are a contraindication for MRI
•Stroke within 90 days prior to screening
•Major surgery within 30 days prior to screening
•Pregnant or breast-feeding women
•Age>75 years old
•Severe systemic disease (cancer, auto-immune etc) accompanied by reduced life expectancy <1 year
•Participation in another trial of an investigational drug or device
•ACTION bleeding risk score>16% at baseline

发起方

ni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.