Acute myocardial infarction
Conditions
Interventions
Group I - CIGB-500 (5,0 mg) (Experimental): CIGB-500 peptide (5.0 mg) applied in intravenous bolus, slow, for 3 minutes. Scheme of 20 administrations: one dose every 12 hours for 10 days + thrombolyti
Peptides
Thrombolytic Therapy
Placebos
CIGB-500 peptide
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Compliance with diagnostic confirmation criteria (patients with a clinical diagnosis of acute myocardial infarction of any location, defined as acute necrosis of a territory of the heart muscle, caused by the occlusion of a coronary artery, usually produced by a thrombus formed on a complicated atherosclerotic plaque). 2. Age between 18 and 80 years, both inclusive. 3. Patient presenting his first acute myocardial infarction (AMI). 4. Time not greater than 12 hours between the onset of symptoms and the beginning of the infusion with thrombolytic therapy / administration of the investigational product. 5. Voluntariness of the patient through the granting of informed consent (oral).
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock as a form of presentation. 2. Active internal bleeding. 3. Neurosurgery or head trauma in the last two months, or intracranial vascular disease (eg, aneurysms, arteriovenous malformations). 4. Recent severe trauma (in the last four weeks). 5. History of CNS haemorrhage, or other recent cerebrovascular event (in the last year). 6. Surgery or biopsy of an organ in the three weeks prior to inclusion in the study. 7. Recent puncture in non-compressible major vessels. 8. Minor trauma with risk (last 10 days), including traumatic or prolonged cardiopulmonary resuscitation. 9. Disorders of hemostasis or use of anticoagulants. 10. Profuse recent gastrointestinal or genitourinary bleeding (in the last three months). 11. Active peptic ulcer. 12. Referred hemorrhagic diabetic retinopathy. 13. Other recent internal bleeding or conditions where there is a risk of major bleeding or would be difficult to manage because of its location. 14. Patients presenting with aortic dissection, septic thrombophlebitis, acute pericarditis or infective endocarditis. 15. Moderate or severe systemic infections that interfere with the patient's evaluation. 16. Severe and uncontrolled arterial hypertension (systolic > 185 mm Hg or diastolic > 110 mm Hg) that does not descend after treatment. 17. Other decompensated chronic diseases (diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 18. Patients diagnosed with malignant neoplasms. 19. History of streptokinase allergy, or any ingredient of the formulations under study. 20. Patients who have been treated with streptokinase in the last six months. 21. Pregnancy or lactation at the time of inclusion (referred by the patient or relative). 22. Obvious mental inability to issue consent and act accordingly with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global morpho-functional recovery of the left ventricle, in particular, the ejection fraction of the left ventricle (percentage of diastolic ventricular diastolic volume that is ejected into the systemic circulation during a systole: <30% Severe; 30-44% Moderate; 45-54% mild, =55% Normal). Measurement time: first 72 hours after the start of treatment, at hospital discharge, and in months 1, 3 and 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mortality (Alive, Dead). Measurement time: at 30 days and at 6 months. - Re-infarction and other complications such as arrhythmia [supraventricular, ventricular, block A / V], shock, cardiac arrest, acute pulmonary edema, heart failure, among others (Yes, No). Measurement time: during the period of execution of the clinical trial (6 months). -Adverse Events (AE)( Occurrence (Yes, No) -Description of the AE (name of the event) -Intensity of the AE (mild, moderate, severe)). Measurement time: daily during hospital admission, and in months 1, 3 and 6. - Vital signs (temperature, blood pressure, heart rate and respiratory rate). Measurement time: daily during hospital admission, and in months 1, 3 and 6. - Electrocardiogram (alterations of the ST segment and in the relation of the QT / QTc interval) (Yes, No, Specify). Measurement time: daily during the hospitalization and in each external evaluation consultation. - Laboratory (numerical values ??of blood tests and blood chemistry, according to units of measurement). Measurement time: at the beginning, the 5th day, the hospital discharge and in months 1, 3 and 6. - Biological markers of cardiac necrosis and ventricular dysfunction (in heparinized venous blood): troponin T, myoglobin, CK-MB, NT pro BNP (numerical values expressed in corresponding units according to the test). Measurement time: at the beginning, 6 and 24 hours, and daily until the hospital discharge. - Pro-inflammatory markers: IL-6, C-reactive protein (numerical values expressed in corresponding units according to the test). Measurement time: to the 5th day, to the hospital discharge and in months 1, 3 and 6. - Markers of the REDOX system: MDA, H2O2, SOD, etc (numerical values expressed in corresponding units according to the determination). Measurement time: to the 5th day, to the hospital discharge and in months 1, 3 and 6. | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed