Acute and long term effects of thyroid hormone replacement therapy in patients with ST-Elevation Myocardial Infarction (STEMI) and borderline/reduced triiodothyronine levels. - THIRST

Conditions: All patients enrolled in the study should be in good clinical conditions, being ST-elevation myocardial infarction the main pathology,, without evidence of clinical/hemodynamic instability. All patients enrolled should present - at admission or within 72 hours after hospital arrival - borderline/reduced plasma levels of triiodothyronine (fT3 <2.2 pg/mL or decrease in fT3 plasma levels major than 20% with respect to the admission levels).
MedDRA version: 9.1Level: SOCClassification code 10007541
MedDRA version: 9.1Level: HLTClassification code 10011085
MedDRA version: 9.1Level: PTClassification code 10028596
MedDRA version: 9.1Level: PTClassification code 10000891

Registration Number: EUCTR2009-010869-23-IT

Lead Sponsor: OSPEDALE G.PASQUINUCCI-FONDAZIONE TOSCANA GABRIELE MONASTERIO/CNR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Male and female patients, all ethnic races, admitted to the Coronary Care Unit for chest pain and subsequently proven STEMI (ST Elevation Myocardial Infarction); Age between 30 to 70 years; Patients subjected to coronary revascularization through PTCA and stenting PTCA performed within 12 hours from the onset of symptoms Evidence of fT3 levels below the lower referral limit (<2.2 pg/mL for our laboratory) or decrease in fT3 plasma levels major than 20% with respect to the admission levels Signature of a written informed consent before randomization
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous myocardial infarction Previous evidence of compromised left ventricular function (Ejection Fraction< 40%) Hemodynamic instability, cardiogenic shock, decompensated heart failure (NYHA IV class) at admission Use of inotropic drugs Thyroid disease Patients assuming: TH replacemement therapy, anti-thyroid drugs, corticosteroids, amiodarone, oral anticoagulant therapy, oral contraceptives Patients presenting atrial fibrillation or with previous documentation of paroximal or persistent atrial fibrillation Pregnant or breast-feeding women Sever systemic diseases including: neoplasia, decompensated diabetes mellitus with glicosilated haemoglobin levels major than 9%, liver cirrhosis, chronic obstructive lung disease with moderate to severe respiratory impairment, chronic kidney failure with creatinine plasma levels major than 3 mg/dL Systemic inflammatory/ autoimmune disease Patients holding mechanical cardiac valves, pace-makers or infusion pumps, magnetic materials like metallic clips and prothesis Patients allergic to synthetic thyroid hormone or any eccipient in the drug eventually administered Patients refusing or unable to supply written informed consent.