CIGB-500 in acute myocardial infarction (AMIGOS study)
Phase 1
Not yet recruiting
- Conditions
- Acute myocardial infarction
- Registration Number
- RPCEC00000177
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), in Havana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1) Compliance with the diagnostic criteria.
2) Patient presenting their first acute myocardial infarction (AMI).
3) Voluntary patient by providing their informed consent (oral).
Exclusion Criteria
1) Cardiogenic shock as a presentation.
2) significant coronary multivessel disease.
3) Patients previously revascularized.
4) diabetics or with a history of pituitary adenoma patients.
5) Patients with a diagnosis of malignancy.
6) Pregnancy or lactation at the time of inclusion in the study (reported by the patient).
7) Mental incapacity apparent consent to issue and act accordingly to the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical adverse event (AE). Measuring time: daily in the 1st week , 1st month weekly (weeks 2, 3 and 4) and monthly until 6 months . EA <br>- Occurrence (Yes, No) <br>- EA Description (name of event) EA <br>- intensity (mild, moderate , severe).<br>Vital signs (temperature, blood pressure, heart rate and respiratory rate). Measuring time: 30 minutes after initiation of treatment, every hour (the first 8 hours) , then every 2 hours (for up to 24 hours) , followed every 4 hours while the patient remains hospitalized. At discharge, each query evaluation.<br>Electrocardiogram (ST-segment abnormalities and the relation of the QT/QTc interval). Measuring time: daily during hospitalization and at each outpatient evaluation.<br>Laboratory (numerical values ??of hematological, biochemical tests and biomarkers). Measuring time: 72 hours at hospital discharge and at months 1, 3 and 6.
- Secondary Outcome Measures
Name Time Method Echocardiographic evidence (study of ventricular function: ejection fraction of the left ventricle, diastolic and systolic left ventricular volume, wall motion score index). Measuring time: 24 hours after primary PTCA, at 72 hours, at 2 and 6 months. <br>Extension of the infarct (by two-dimensional echocardiography and scintigraphy). Measuring time: at baseline and at 4-6 weeks post-inclusion. <br>Pro-inflammatory markers (IL-1ß, IL-6, CRP, TNF alpha). Measuring time: at 12, 24 and 72 hours, the 5th day and at hospital discharge. <br>Markers REDOX system (MDA, H2O2, peroxidation potential serum SOD, CAT, GSH, NO FLAP FRAP, ferric reducing ability of iron, PAOP). Measuring time: 72 hours and at hospital discharge.