Acute Myocardial Infarction and endothelial function. Assessment with a non invasive ultrasonographic computerized method during oral vitamin C supplementation. - FIMAVIC
- Conditions
- Patients affected by non fatal new myocardial infarction (STEMI and N-STEMI)MedDRA version: 12.0Level: LLTClassification code 10000891Term: Acute myocardial infarction
- Registration Number
- EUCTR2009-013198-16-IT
- Lead Sponsor
- IVERSITA` DEGLI STUDI DI PARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-Patients of either gender, age> 25 years and < 60 -With a new non fatal AMI (STEMI NSTEMI) -Patients gave their 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-patients suffered from cardiogenic shock, hypotension ( systolic blood pressure less than 100 mmHg for at least 30 minutes, pulmonary oedema, mayor arrhythmias, -without major systemic illnesses -renal insufficiency (GFR < 30 ml/min) and -pregnancy or oral contraceptives -Alcoholism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -Examine the time-course of endothelial function using a new noninvasive computerized technique (flow mediated dilation, FMD) in patients with AMI (acute phase and 20 40 days after). -Asses the benefit of vitamin C oral administration (500 mg/24h) on endothelial dysfunction in patients with non fatal new myocardial infarction .;Secondary Objective: -Evaluate the effects of vitamin C oral administration (500 mg/24h) on serum concentrations of the main systemic and vascular inflammation markers.;Primary end point(s): Endothelial function improvement
- Secondary Outcome Measures
Name Time Method