REDUCCION DEL TAMAÑO DEL INFARTO. REDUCTION OF INFARCT SIZE. MedDRA version: 9.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Trade Name: ADENOCOR 6 mg/2 ml solucion inyectable
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ADENOSINA
CAS Number: 58-61-7
Other descriptive name: ADENOSINE
Concentration unit: m
Sponsors
VALLE HEBRON HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - PATIENTS OLDER THAN 18. - PATIENTS WITH ACUTE CORONARY SYNDROME WITH ST SEGMENT ELEVATION WITHIN SIX HOURS OF THE ONSET OF SYMPTOMS. 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 YOUNGER THAN 18 AND PREGNANT WOMEN. - PATIENTS WITH PREVIOUS TRANSMURAL INFARCT. - PATIENTS WITH CLINICAL EVIDENCE OF BRONCHOSPASTIC LUNG SISEASE OR PRIOR BRONCHODILATOR THERAPY. - PATIENTS WITH PACEMAKERS. - PATIENTS PRESENTING TIMI FLOW BETWEEN 3 AND 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - TO EVALUATE THE SAFETY AND EFFICACY OF A BRIEF INTRACORONARY INFUSION OF ADENOSINE APPLIED AT THE TIME OF REPERFUSION TO LIMIT INFARCT SIZE AND LV REMODELLING IN PATIENTS WITH ACUTE CORONARY SYNDROME WITH ST SEGMENT ELEVATION, SUBMITTED TO PTCA.;Secondary Objective: - MODIFICATION OF CLINICAL PRACTICE GUIDELINES RECOMMENDATIONS.;Primary end point(s): - INFRARCT SIZE MEASURED BY MAGNETIC RESONANCE IMAGING. | — |
Countries
Spain
Outcome results
None listed