NCT02062554

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

13.7 years

First QC Date

February 12, 2014

Last Update Submit

March 21, 2019

Conditions

ST-Elevation Myocardial Infarction

Keywords

Myocardial infarctionClinical outcomeFlow-mediated dilationInflammation

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    30 days

Secondary Outcomes (2)

  • Major cardiovascular events

    2 years

  • All cause mortality

    2 years

Other Outcomes (2)

  • Endothelial Function

    30 days

  • Left Ventricular Remodeling

    30 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ST-elevation Myocardial Infarction patients admitted to Hospital de Base de Distrito Federal, Brasilia, Brazil

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment
  • Patients unable to attend follow-up
  • Concomitant diseases with short-term survival expectancy, i.e. cancer, severe COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Campinas

Campinas, São Paulo, 13083-887, Brazil

RECRUITING

Related Publications (14)

  • 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 associated with the inflammatory activity during acute phase myocardial infarction. Inflammation. 2014 Jun;37(3):678-85. doi: 10.1007/s10753-013-9784-y.

    PMID: 24282109RESULT

  • 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. 2013 Nov;29(11):1423-7. doi: 10.1185/03007995.2013.832186. Epub 2013 Sep 4.

    PMID: 23927444RESULT

  • 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 myocardial infarction: a study by euglycemic hyperinsulinemic clamp. J Clin Lipidol. 2013 Jan-Feb;7(1):24-8. doi: 10.1016/j.jacl.2012.10.003. Epub 2012 Oct 26.

    PMID: 23351579RESULT

  • Costa AP, de Paula RC, Carvalho GF, Araujo 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, cardiac remodelling and mortality after myocardial infarction. Atherosclerosis. 2012 May;222(1):284-91. doi: 10.1016/j.atherosclerosis.2012.02.037. Epub 2012 Mar 3.

    PMID: 22436606RESULT

  • 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. doi: 10.1016/j.atherosclerosis.2011.09.044. Epub 2011 Oct 4.

    PMID: 22018645RESULT

  • Sposito AC, Alvarenga BF, Alexandre AS, Araujo 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 based on clinical algorithms or plasma C-reactive protein. Atherosclerosis. 2011 Jan;214(1):148-50. doi: 10.1016/j.atherosclerosis.2010.10.034. Epub 2010 Nov 3.

    PMID: 21115179RESULT

  • Sposito AC, Carvalho LS, Cintra RM, Araujo 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. 2009 Nov;207(1):191-4. doi: 10.1016/j.atherosclerosis.2009.04.008. Epub 2009 Apr 17.

    PMID: 19464010RESULT

  • 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. Am J Cardiol. 2009 Feb 15;103(4):461-3. doi: 10.1016/j.amjcard.2008.10.007. Epub 2008 Dec 25.

    PMID: 19195502RESULT

  • 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 independently associated with endothelial dysfunction and adverse clinical outcome. Atherosclerosis. 2014 Dec;237(2):777-83. doi: 10.1016/j.atherosclerosis.2014.10.104. Epub 2014 Nov 4.

    PMID: 25463120RESULT

  • 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 vasodilation and nitric oxide bioavailability. Atherosclerosis. 2014 Dec;237(2):840-6. doi: 10.1016/j.atherosclerosis.2014.10.103. Epub 2014 Nov 4.

    PMID: 25463131RESULT

  • Machado-Silva W, Alfinito-Kreis R, Carvalho LS, Quinaglia-E-Silva JC, Almeida OL, Brito CJ, Ferreira AP, Cordova C, Sposito AC, Nobrega OT; Brasilia Heart Study Group. Endothelial nitric oxide synthase genotypes modulate peripheral vasodilatory properties after myocardial infarction. Gene. 2015 Sep 1;568(2):165-9. doi: 10.1016/j.gene.2015.05.042. Epub 2015 May 20.

    PMID: 26002446RESULT

  • 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 reperfusion therapy in acute myocardial infarction. Coron Artery Dis. 2015 Nov;26(7):562-6. doi: 10.1097/MCA.0000000000000269.

    PMID: 26010531RESULT

  • Barreto J, Matos LCV, Quinaglia JC, Sposito AC, Carvalho LS. The impact of low income on long-term mortality of myocardial infarction patients: results from the Brazilian Heart Study. Curr Med Res Opin. 2021 Oct;37(10):1689-1695. doi: 10.1080/03007995.2021.1965561. Epub 2021 Aug 17.

    PMID: 34374619DERIVED

  • Campos-Staffico AM, Costa APR, Carvalho LSF, Moura FA, Santos SN, Coelho-Filho OR, Nadruz W Jr, Quinaglia E Silva JC, Sposito AC; Brasilia Heart Study. Omega-3 intake is associated with attenuated inflammatory response and cardiac remodeling after myocardial infarction. Nutr J. 2019 May 6;18(1):29. doi: 10.1186/s12937-019-0455-1.

    PMID: 31060562DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Leucocyte DNA

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial InfarctionInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Andrei C Sposito, PhD MD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei C Sposito, PhD MD

CONTACT

55 19 3251-8788brasiliaheartstudy@gmail.com

Valeria N Figueiredo, PhD

CONTACT

55 19 3251-8788brasiliaheartstudy@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor PhD MD

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 13, 2014

Study Start

May 1, 2006

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

BR(1)