ISCHAEMIC ARTERY DISEASE MedDRA version: 9.1 Level: LLT Classification code 10028595 Term: Myocardial infarct
Conditions
Interventions
Trade Name: DIBASE*OS GTT 10ML 10000UI/ML
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Colecalciferol
Concentration unit: IU international unit(s)
Concentration type: equal
Concentra
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes 60-80 year old, admitted in hospital for acute coronary syndrome (unstable angina, acute myocardial infarction). No clinical evidence of heart failure (class 1 according to the classification of the New York Heart Association) 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
Exclusion criteria: Hypercalcemia and / or hypercalciuria, nephrolithiasis, chronic renal failure (creatinine clearance <60 ml / min) Patients suffering from chronic diseases (onco-haematological, endocrinological, nutritional, rheumatic, COPD) which can affect bone metabolism Congestive heart failure NYHA ≥ 2 and / or cardiac arrhythmias Patients already in therapy with supplements of calcium and vitamin D Drugs which can affect calcium phosphoric metabolism: cortisone, l-thyroxine in soppressive dose, phenytoin, phenobarbital, chemotherapy drugs (type methotrexate or other antimetabolites), GnRH agonists, progesterone depot, aromatase inhibitors, lithium, antacids chelating phosphates, tetracycline, phenothiazine, cyclosporine, tacrolimus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Myocardial infarction, coronary syndrome, revascularisation procedure on a coronary artery Revascularisation procedure on a peripheral artery Stroke Transient ischaemic cerebral attack documented on a neurological consult in hospital Amputation for ischemic event Sudden death from cardiovascular causes Deep-vein thrombosis, pulmonary thromboembolism;Secondary Objective: Glycemia, Insulin, Homa Index (in diabetic patient: HBA1c) Total cholesterol and HDL Triglycerides Blood pressure Bone mass Quality of life;Primary end point(s): Myocardial infarction, coronary syndrome, revascularisation procedure on a coronary artery Revascularisation procedure on a peripheral artery Stroke Transient ischaemic cerebral attack documented on a neurological consult in hospital Amputation for ischemic event Sudden death from cardiovascular causes Deep-vein thrombosis, pulmonary thromboembolism | — |
Countries
Italy
Outcome results
None listed