Acute coronary syndrome Circulatory System Acute coronary syndrome
Conditions
Interventions
Patients are randomised to one of two protocols of glycaemic control.
Intervention group (therapy A): intensive treatment. The aim was to obtain a glycaemia of 80 to 120 mg/dl (4.44 to 6.66 mmol/l).
Sponsors
Hospital Clínico San Carlos, Instituto Cardiovascular (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consecutive patients admitted to the Coronary Care Unit with ACS and hyperglycaemia will be enrolled if they meet the following criteria: 1. Chest pain in the 24 hours previous to their inclusion 2. Older than 18 years 3. Written informed consent 4. Participant must have one of the following: 4.1. ST segment elevation of at least 0.1 mV in two or more adjacent leads 4.2. New onset left bundle branch block 4.3. ST segment depression of at least 0.1 mV in two or more adjacent leads 4.4. Markers of myocardial necrosis (cardiac troponin I above normal levels) 5. Participants must have one of the following: 5.1. Known diabetes and glycaemia greater than 120 mg/dl (6.66 mmol/l) on admission 5.2. No diagnosis of diabetes and glycaemia greater than 160 mg/dl (8.88 mmol/l) on admission 5.3. No diagnosis of diabetes and glycaemia between 120 to 160 mg/dl at admission, and greater than 120 mg/dl one hour later
Exclusion criteria
Exclusion criteria: 1. Women of childbearing age 2. Inclusion in another clinical trial 3. Life expectancy of less than 1 year 4. High probability of loss on follow-up 5. Unclear origin of chest pain 6. Patients with scheduled percutaneous coronary interventions with complications during the procedure and are admitted to the Coronary Unit, but without chest pain in the last 24 hours 7. Patients on mechanical ventilation 8. Ethical barriers (e.g., patients who are not fluent in Spanish, relatives of investigators) 9. Glycaemia greater than 400 mg% (22.20 mmol/l) on admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effects of treatment on platelet reactivity. Platelet reactivity at baseline, 24 and 48 hours will be assessed by the following: 1.1. Platelet activation: flow cytometry; analysis of platelet P-selectin and GPIIb/IIIa, basal and activated with ADP (1 and 5 µM) and thrombin receptor activating peptide (TRAP) (1 and 5 µM) 1.2. Intracellular expression of vasodilator-stimulated phosphoprotein (VASP) 1.3. Soluble sCD40L 1.4. Platelet aggregation 2. Metabolic study: free fatty acids, leptin, adiponectin, and ßOH-butirate. They will be assessed at baseline, 24 and 48 hours, 3, 6, 9 and 12 months of follow-up 3. Influence of platelet polymorphisms on treatment effects. Genetic polymorphisms will be assessed by polymerase chain reaction (PCR) for P-selectin receptor, platelet ADP receptor and phospholipase A2 receptor (PLA2) receptor of GPIIb/IIIa | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/08/2009: Association between the parameters above and cardiovascular major events during follow-up, between different levels of glycaemia, different evolution of diabetes mellitus (quantified by HbA1c, ages of evolution, type of treatment) Previous secondary outcome measures: Clinical outcome: association between the parameters above and cardiovascular major events during follow-up. Cardiovascular major events (death, reinfarction, angina, revascularisation, ictus, cardiogenic shock, pulmonary oedema) during follow-up will be recorded. | — |
Countries
Spain
Outcome results
None listed