Contrast indiced nephropaty (CIN) in patients undergoing primary angioplasty for acute myocardial infarction. Randomized trial on the effects of hydration with saline or sodium bicarbonate. - ND
- Conditions
- AMIMedDRA version: 6.1Level: SOCClassification code 10007541
- Registration Number
- EUCTR2007-002149-20-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- age >18 years
- tipycal chest pain lasting 30 min. associated with ST elevation of 0.2 mV in at least 2 leads or LBB
- informed consent available
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
- substitutive renal treatment
- coronary anatomy not suitable for angioplasty
- need for emergency coronary by pass
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the lower risk of CIN in patients with AMI undergoing primary PCI after hydration with NA bicarbonate or NA CL;Secondary Objective: In hospital MACE (death, acute renal insufficiency, major bleeding, re-AMI);Primary end point(s): CIN incidence evaluated by an increase of 25% of basal creatinine or 0,5 mg/dl as absolute value.
- Secondary Outcome Measures
Name Time Method