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: 9.1 Level: SOC Classification code 10007
Conditions
Interventions
Trade Name: LIOTIR
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Liothyronine sodium
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
OSPEDALE G.PASQUINUCCI-FONDAZIONE TOSCANA GABRIELE MONASTERIO/CNR
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate 1)the safety and feasibility of synthetic thyroid hormone replacement therapy with a triiodothyronine analogue (Liotir) in patients with STEMI both in the acute (in hospital period) and chronic phase (after hospital discharge) of coronary artery disease and its association with cardiac function and outcome; 2) the effects of thyroid hormone replacement therapy on clinical outcome in terms of major (cardiac and non cardiac death, reinfarction) and minor (recurrence of angina, coronary revascularization, and hospital re-admission) events.;Secondary Objective: To evaluate the effects of thyroid hormone therapy on: Infarct size, regional wall motion abnormalities, systolic and diastolic myocardial function; Neuroendocrine imbalance; Patients functional capacity, quality of life, cognitive and behavioural status;Primary end point(s): To evaluate the effects of TH replacement therapy in patients with STEMI and borderline/reduced fT3 plasma levels on outcome and major (cardiac and non cardiac death, reinfarction) and minor (angina, coronary revascularization, hospitalization) adverse cardiac events . | — |
Countries
Italy
Outcome results
None listed