Coronary artery disease, aortic stenosis MedDRA version: 16.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 16.1 Level: PT Classification code 10002906 Term: Aortic stenosis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Adenocor 3 mg/ml inj.
Product Name: Adenocor 3 mg/ml
Product Code: C01EB10
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Infusion
Route of administration of the placeb
Sponsors
TAYS Sydänsairaala
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: elective surgery for coronary artery disease or aortic valve stenosis 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: inability to comprehend the study protocol emergent operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: myocardial function after cardiac surgery;Secondary Objective: markers of inflammation in myocardium;Primary end point(s): global myocardial strain time to asystole ;Timepoint(s) of evaluation of this end point: pre and post cardiopulmonary bypass after aortic clamping, postclamping | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): inflammatory markers in myocardium and blood;Timepoint(s) of evaluation of this end point: baseline/ 6 hr/ 18 hr after cardiopulmonary bypass | — |
Countries
Finland
Outcome results
None listed