AMI MedDRA version: 6.1 Level: SOC Classification code 10007541
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Electrolytes
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7140-
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - substitutive renal treatment - coronary anatomy not suitable for angioplasty - need for emergency coronary by pass
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed