Patients with Acute Coronary syndromes MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN
Concentration unit: IU international unit(s)
Sponsors
A. N. M. C. O. - FONDAZIONE ITALIANA LOTTA MALATTIE CARDIOVASCOLARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of any age and gender - ACS with or without ST elevation [abnormal ischemic EKG changes (ST-elevation, ST depression, negative T waves or new LBBB)] and positive cardiac markers within 24 hours from the onset of symptoms - whole-blood glucose on admission in CCU >=140 mg/dl. - Informed consent at enrollment is required to be included in the study. 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: - Unstable angina (ACS without EKG and cardiac biomarkers abnormalities); - Former history of type 1 diabetes; - Hepato-biliary obstructive disease or other severe liver disease; - End-stage renal disease (dialysis or indication for kidney transplantation is required); - Terminal illness or co-morbidities with life expectancy <24 months; - Conditions associated with poor compliance with the study (alcoholism, mental illness, or drug dependence, etc.); - Unwilling to participate to the study or already enrolled in other interventional protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate if an intensified, targeted, multifactorial intervention strategy aimed at several modifiable risk factors (hypertension, dyslipidemia) may improve the outcomes of patients with ACS and hyperglycemia (blood glucose >=140 mg/dl and <200 mg/dl) on admission;Secondary Objective: the study evaluates whether impaired glucose tolerance (IFG or IGT) detected during hospitalization for ACS is associated with a worse outcome;Primary end point(s): A composite of cardiovascular mortality, non fatal infarction, non fatal stroke or heart failure | — |
Countries
Italy
Outcome results
None listed