A clinical study to check the efficacy of triiodothyronine on cardiac performance of patients after myocardial infarctio

Phase 1

• Conditions: Patients with anterior or anterolateral STEMI subjected to primary PCI.; MedDRA version: 20.0Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000631-40-GR
• Lead Sponsor: ni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified