Acute coronary syndrome ST-elevation patients MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Trade Name: KRENOSIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adenosine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ・ patients with symptoms and signs of acute myocardial infarction, referred within six hours from symptom onset to cat lab ・ patients at their first AMI 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: ・ patients referred to cat lab over the time ・ patients with previous MI ・ patients with contraindications to PTCA or failure to perform it or that refuse it
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ・ to confirm the protective effect of adenosine on reperfusion injury ・ to confirm the protective effect of post conditioning on reperfusion injury ・ to compare these two strategies ・ to asses the results of reperfusion injury on microcirculation function and global and regional left ventricular function ・ to define time and interaction of microcirculation disfunction and left ventricular function due to ischaemia-reperfusion injury ・ to validate 3D echocardiography by comparing with cardiac MRI;Secondary Objective: ・ to asses the recovery of function obtained by primary PCI ・ to understand the right time for PCI and reperfusion injury, to obtain the function recovery ・ to value infarct size by cardiac MRI;Primary end point(s): ・ to confirm the protective effect of adenosine on reperfusion injury | — |
Countries
Italy
Outcome results
None listed