NCT02428374

Role of Immune Responses After Acute Myocardial Infarction

Role of Innate and Adaptive Immunity After Acute Myocardial Infarction BATTLE-AMI Study (B And T Types of Lymphocytes Evaluation in Acute Myocardial Infarction)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The fascinating role of lymphocyte subtypes in the development of coronary artery disease may be a new strategic target for understanding and therapy of acute myocardial infarction. The determinants of cell viability are unknown, postulating that they arise from factors not only related to microcirculation or energy expenditure, but also to inflammatory and immune responses. Furthermore, the intense mobilization of progenitor cells secondary to myocardial infarction triggers large lymphocyte proliferation that colonizes plaques in development, contributing to recurrent ischemic outcomes. This project aims to evaluate the immune and metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary disease progression.

Detailed description

Specifically, the investigators will study the innate and adaptive immunity, with emphasis on lymphocytes subtypes involved in the early and late surrogate outcomes of patients with acute myocardial infarction, their characterization (B1, B2 and T lymphocytes) in cell culture and by flow-cytometry, and immune responses (IgM and IgG for oxLDL and specific epitopes of apoB). In addition, the project will evaluate new biomarkers identified by studies of metabolomics, as well as the corresponding signaling pathways. Therapeutic pharmacological strategies and changes on intestinal microbiota will be evaluated since the acute phase of myocardial infarction up to 6 months. In the study, the investigators will compared four arms of combined therapy: clopidogrel with rosuvastatin; or clopidogrel with simvastatin; or ticagrelor with rosuvastatin; or ticagrelor with simvastatin. The investigator's hypothesis is that the improvement of microcirculation with rosuvastatin and ticagrelor (synergic pleiotropic effects) may decrease the infarcted mass area, resulting in better left ventricular ejection fraction when compared to the other combined therapies. The monitoring and genotype of microbiota will be examined together the metabolomics and cardiac MRIs obtained at the acute phase of MI and after 1-mo and 6-mo FU.

Conditions

• Myocardial Fibrosis

Interventions

Type	Name	Description
DRUG	Rosuvastatin plus clopidogrel	Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
DRUG	Rosuvastatin plus ticagrelor	Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo
DRUG	Simvastatin plus clopidogrel	Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
DRUG	Simvastatin plus ticagrelor	Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-04-01
• Completion: 2019-07-01
• First posted: 2015-04-28
• Last updated: 2015-06-11

Locations

1 site across 1 country: Brazil