EFFECT OF SUPPLEMENTATION WITH CHOLECALCIFEROL ON GLUCOSE AND LIPID METABOLISM, BLOOD PRESSURE, BONE MASS, QUALITY OF LIFE, CARDIOVASCULAR MORBIDITY AND MORTALITY IN PATIENTS WITH ISCHAEMIC HEART DISEASE - ND

Conditions: ISCHAEMIC ARTERY DISEASE
MedDRA version: 9.1Level: LLTClassification code 10028595Term: Myocardial infarct

Registration Number: EUCTR2008-004220-23-IT

Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

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

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Myocardial infarction, coronary syndrome, revascularisation procedure on a coronary artery<br>Revascularisation procedure on a peripheral artery<br>Stroke<br>Transient ischaemic cerebral attack documented on a neurological consult in hospital<br>Amputation for ischemic event<br>Sudden death from cardiovascular causes<br>Deep-vein thrombosis, pulmonary thromboembolism;Secondary Objective: Glycemia, Insulin, Homa Index (in diabetic patient: HBA1c)<br>Total cholesterol and HDL<br>Triglycerides<br>Blood pressure<br>Bone mass<br>Quality of life;Primary end point(s): Myocardial infarction, coronary syndrome, revascularisation procedure on a coronary artery<br>Revascularisation procedure on a peripheral artery<br>Stroke<br>Transient ischaemic cerebral attack documented on a neurological consult in hospital<br>Amputation for ischemic event<br>Sudden death from cardiovascular causes<br>Deep-vein thrombosis, pulmonary thromboembolism

Secondary Outcome Measures