Iperglycemia with Acute Coronary Syndrome MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Trade Name: HUMULIN R*1F 10ML 100U/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin (human)
Concentration unit: IU international unit(s)
Concentration type: equal
Concentrat
Sponsors
Istituto Fisiologia Clinica, CNR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization; an elevated cardiac troponin T levels (>=0.03 mcg per liter); and either electrocardiographic evidence of ischemia on admission or a documented history of coronary artery disease 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: known diabetes at the admission, an age younger than 18 years or older than 80 years, myocardial infarction with ST-segment elevation in the past 48 hours, or inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Endothelial function, coronary flow reserve.;Main Objective: assess in patients with acute coronary syndromes (ACS) the effects of strict (with intensive insulin therapy) vs. conventional therapy on endothelial function, coronary flow reserve and left ventricular contractility;Secondary Objective: ND | — |
Countries
Italy
Outcome results
None listed