ST-Elevation Myocardial Infarction Clinical Trial
— BHSOfficial title:
Brasilia Heart Study of Outcome Markers in ST-elevation Myocardial Infarction
NCT number | NCT02062554 |
Other study ID # | BHS-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2006 |
Est. completion date | January 2020 |
BHS is a cohort study of consecutive myocardial infarction (MI) patients admitted within the first 24 hours of symptoms and has been ongoing since May of 2006. The purpose of this study is to assess for possible markers for increased risk after MI.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - less than 24 hours after the onset of MI symptoms - ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads - myocardial necrosis, as evidenced by increase to at least one value above the 99th percentile above the reference limit of CK-MB (25 U/L) and troponin I (0·04 ng/mL) followed by a decline of both Exclusion Criteria: - Cognitive impairment - Patients unable to attend follow-up - Concomitant diseases with short-term survival expectancy, i.e. cancer, severe COPD |
Country | Name | City | State |
---|---|---|---|
Brazil | State University of Campinas | Campinas | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil | University of Brasilia |
Brazil,
Carvalho LS, Cintra RM, Moura FA, Martins NV, Quinaglia E Silva JC, Coelho OR, Sposito AC; Brasilia Heart Study Group. High plasma HDL-C attenuates stress hyperglycemia during acute phase of myocardial infarction. Atherosclerosis. 2012 Jan;220(1):231-6. d — View Citation
Carvalho LS, Martins NV, Moura FA, Cintra RM, Almeida OL, Quinaglia e Silva JC, Sposito AC; Brasilia Heart Study Group. High-density lipoprotein levels are strongly associated with the recovery rate of insulin sensitivity during the acute phase of myocard — View Citation
Carvalho LS, Panzoldo N, Santos SN, Modolo R, Almeida B, Quinaglia E Silva JC, Nadruz W Jr, de Faria EC, Sposito AC; Brasilia Heart Study Group. HDL levels and oxidizability during myocardial infarction are associated with reduced endothelial-mediated vas — View Citation
Carvalho LS, Virginio VW, Panzoldo NB, Figueiredo VN, Santos SN, Modolo RG, Andrade JM, Quinaglia E Silva JC, Nadruz-Junior W, de Faria EC, Sposito AC; Brasilia Heart Study Group. Elevated CETP activity during acute phase of myocardial infarction is indep — View Citation
Costa AP, de Paula RC, Carvalho GF, Araújo JP, Andrade JM, de Almeida OL, de Faria EC, Freitas WM, Coelho OR, Ramires JA, Quinaglia e Silva JC, Sposito AC; Brasilia Heart Study Group. High sodium intake adversely affects oxidative-inflammatory response, c — View Citation
Figueiredo VN, Godoi FC, Martins NS, Quinaglia e Silva JC, Nadruz W Jr, Coelho OR, Sposito AC; Brasilia Heart Study Group. Diabetes mellitus unawareness is a strong determinant of mortality in patients manifesting myocardial infarction. Curr Med Res Opin. — View Citation
Machado-Silva W, Alfinito-Kreis R, Carvalho LS, Quinaglia-E-Silva JC, Almeida OL, Brito CJ, Ferreira AP, Córdova C, Sposito AC, Nóbrega OT; Brasilia Heart Study Group. Endothelial nitric oxide synthase genotypes modulate peripheral vasodilatory properties — View Citation
Modolo R, Figueiredo VN, Moura FA, Almeida B, Quinaglia e Silva JC, Nadruz W Jr, Lemos PA, Coelho OR, Blaha MJ, Sposito AC; Brasilia Heart Study Group. Coronary artery calcification score is an independent predictor of the no-reflow phenomenon after reper — View Citation
Quinaglia e Silva JC, Coelho-Filho OR, Andrade JM, Quinaglia T, Modolo RG, Almeida BO, van der Geest RJ, Jerosch-Herold M, Coelho OR, Sposito AC; Brasilia Heart Study Group. Peri-infarct zone characterized by cardiac magnetic resonance imaging is directly — View Citation
Quinaglia e Silva JC, Munhoz DB, Morato TN, Gurgel A, Macedo AC, Sever P, Sposito AC; Brasilia Heart Study Group. Effect of beta blockers (metoprolol or propranolol) on effect of simvastatin in lowering C-reactive protein in acute myocardial infarction. A — View Citation
Sposito AC, Alvarenga BF, Alexandre AS, Araújo AL, Santos SN, Andrade JM, Ramires JA, Quinaglia E Silva JC, Coelho OR; Brasilia Heart Study Group. Most of the patients presenting myocardial infarction would not be eligible for intensive lipid-lowering bas — View Citation
Sposito AC, Carvalho LS, Cintra RM, Araújo AL, Ono AH, Andrade JM, Coelho OR, Quinaglia e Silva JC; Brasilia Heart Study Group. Rebound inflammatory response during the acute phase of myocardial infarction after simvastatin withdrawal. Atherosclerosis. 20 — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Endothelial Function | Assessment of endothelial function on brachial artery. The flow-mediated dilation was measured. | 30 days | |
Other | Left Ventricular Remodeling | Left Ventricular (LV) Remodeling as indicated by LV end-diastolic diameter (LVEDD), LV end-systolic diameter (LVESD), LV septum diastolic thickness (SD) and posterior wall diastolic thickness (PD). | 30 days | |
Primary | All cause mortality | 30 days | ||
Secondary | Major cardiovascular events | Sudden cardiac death (unrelated to trauma, unexpected, and occurring in less than six hours after onset of symptoms), fatal MI (any death preceded by MI) or non-fatal MI. | 2 years | |
Secondary | All cause mortality | 2 years |
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