Role of Immune Responses After Acute Myocardial Infarction

Myocardial Fibrosis Clinical Trial

— BATTLE-AMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02428374
• Other study ID #: EPM/UNIFESP
• Secondary ID: FAPESP
• Status: Recruiting
• Phase: Phase 4
• First received: March 10, 2015
• Last updated: June 10, 2015
• Start date: May 2015
• Est. completion date: July 2019

Study information

• Verified date: June 2015
• Source: Federal University of São Paulo
• Contact: Francisco A Fonseca, MD, PhD
• Phone: +55 11 992639082
• Email: fahfonseca[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Stable patients with ST elevation myocardial infarction (STEMI) treated with thrombolytics in the first 6h or the initial of symptoms of MI.

Exclusion Criteria:

1. Contraindication or known intolerance to the study drug protocol

2. Those with comorbidities such as neoplasm, renal insufficiency (stage 4 or higher)

Patients should be randomized in the first 24 hours of AMI and treated by one of the four combined therapies at least 2h prior to coronary angiogram followed by percutaneous intervention when necessary.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Fibrosis
• Myocardial Infarction

Intervention

Drug:
• Rosuvastatin plus clopidogrel
Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
• Rosuvastatin plus ticagrelor
Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo
• Simvastatin plus clopidogrel
Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
• Simvastatin plus ticagrelor
Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Locations

Country	Name	City	State
Brazil	Hospital Sao Paulo - UNIFESP	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	FAPESP - Fundação de Apoio à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (114)

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* Note: There are 114 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between gut microbiota and diabetes status after STEMI	Intestinal microbiota will be genotyped and diabetes status (non-diabetic, pre-diabetic or diabetic) according to HbA1c levels.	1-3d	No
Other	Relationship between gut microbiota and diabetes status after STEMI	Intestinal microbiota will be genotyped and diabetes status (non-diabetic, pre-diabetic or diabetic) according to HbA1c levels.	1-mo	No
Other	Relationship between gut microbiota and diabetes status	Intestinal microbiota will be genotyped and diabetes status (non-diabetic, pre-diabetic or diabetic) according to HbA1c levels.	6-mo	No
Other	Relationship between gut microbiota and metabolomics	Intestinal microbiota will be genotyped and metabolomics by LC/MS-MS	1-3d	No
Other	Relationship between gut microbiota and metabolomics	Intestinal microbiota will be genotyped and metabolomics by LC/MS-MS	1-mo	No
Other	Relationship between gut microbiota and metabolomics	Intestinal microbiota will be genotyped and metabolomics by LC/MS-MS	6-mo	No
Other	Comparison between the four arm of combined therapies on microparticles and endothelial progenitor cells	Endothelial, platelet, and monocyte-derived microparticles as well as endothelial progenitor cells will be quantified by flow-cytometry	1-d	No
Other	Comparison between the four arm of combined therapies on microparticles and endothelial progenitor cells	Endothelial, platelet, and monocyte-derived microparticles as well as endothelial progenitor cells will be quantified by flow-cytometry	1-mo	No
Other	Comparison between the four arm of combined therapies on microparticles and endothelial progenitor cells	Endothelial, platelet, and monocyte-derived microparticles as well as endothelial progenitor cells will be quantified by flow-cytometry	6-mo	No
Other	Correlation between the severity of coronary disease with antibodies against oxidized LDL and peptide D of apolipoprotein B of LDL	Antibodies IgG and IgM against oxidized LDL as well as against peptide D of LDL will be quantified by ELISA. Coronary disease severity will be quantified by the Gensini Score	1-d	No
Other	Comparison between the four arms of combined therapies on TIMI flow grade and blush grade	TIMI flow grade and blush grade will be determined based on coronary angiogram obtained at baseline by two independent and blinded certified invasive cardiologists	1-d	No
Other	Relationship between no-reflow images obtained at MRI with metabolomics	Metabolomics will be determined by LC/MS-MS and images by MRI	1-d	No
Other	Relationship between no-reflow images obtained at MRI with metabolomics	Metabolomics will be determined by LC/MS-MS and images by MRI	1-mo	No
Other	Relationship between no-reflow images obtained at MRI with metabolomics	Metabolomics will be determined by LC/MS-MS and images by MRI	6-mo	No
Primary	Comparison of the left ventricular function (MRI) between the four combined treatments, after STEMI	The effects of treatments on the left ventricular function will be measured by MRI	1-mo	No
Secondary	To compare the effects of the four combined therapies on the left ventricular function after STEMI	Variables will be examined by MRI	3-d	No
Secondary	To compare the effects of the four combined therapies on the left ventricular function after STEMI	Variables will be examined by MRI	6-mo	No
Secondary	To compare the effects of the four combined therapies on the infarcted mass area after STEMI	Variables will be examined by MRI	1-mo	No
Secondary	To compare the effects of the four combined therapies on the infarcted mass area after STEMI	Variables will be examined by MRI	6-mo	No
Secondary	To compare the effects of the four combined therapies on the percentage of subjects with left ventricular ejection fraction < 40% after STEMI	Variables will be examined by MRI	1-mo	No
Secondary	To compare the effects of the four combined therapies on the percentage of subjects with left ventricular ejection fraction < 40% after STEMI	Variables will be examined by MRI	6-mo	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI	Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI	1-d	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI	Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI	1-mo	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI	Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI	6-mo	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI	Lymphocyte subtypes quantified by flow-cytometry and infarcted mass area by MRI	1-d	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI	Lymphocyte subtypes quantified by flow-cytometry and infarcted mass area by MRI	1-mo	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI	Lymphocyte subtypes quantified by flow-cytometry and infarcted mass area by MRI	6-mo	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI	Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI	1-d	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI	Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI	1-mo	No
Secondary	To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI	Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI	6-mo	No