NCT02366104

Brief Summary

BSHA is a cohort study of healthy elderlies enrolled voluntarily. It has been ongoing since December 2008. And the purpose of this study is to assess clinical and biological markers of cardiovascular risk in very elderly participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

December 1, 2008

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

8 years

First QC Date

February 11, 2015

Last Update Submit

March 21, 2019

Conditions

Keywords

Cardiovascular DiseasesAgedPrimary Prevention

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    1 year

Secondary Outcomes (1)

  • Major cardiovascular events

    2 years

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-institutionalized outpatients under preventive care were voluntarily enrolled into the study. Participants were aged of 80 years or over, have never manifested myocardial infarction, stroke or peripheral arterial disease.

You may qualify if:

  • Aged of 80 years or over

You may not qualify if:

  • Manifested atherosclerotic disease (MI, stroke or peripheral arterial disease) according to medical evaluation, electrocardiogram and echocardiogram
  • Functional dependence or institutionalization
  • Cognitive impairment assessed by mini-mental state examination (\< 13 points)
  • Use of any anti-inflammatory in the last 30 days
  • Current or previous diagnosis of neoplastic or immune inflammatory disease
  • Chronic obstructive pulmonary disease
  • Glomerular filtration rate \< 25 mL/min/1.73 m2
  • Hepatic disease (ALT or AST ≥ 1.5 upper reference limit)
  • Chronic infectious disease (≥ 3 months)
  • Left ventricular ejection fraction \< 50% on echocardiography
  • Manifested neoplasia at admission or until the first year after enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Biocárdios - Instituto de Cardiologia

Brasília, Federal District, Brazil

Location

University of Campinas

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (6)

  • Freitas WM, Quaglia LA, Santos SN, de Paula RC, Santos RD, Blaha M, Rivera JJ, Cury R, Blumenthal R, Nadruz-Junior W, Agatston A, Figueiredo VN, Nasir K, Sposito AC; Brazilian Study on Healthy Aging. Low HDL cholesterol but not high LDL cholesterol is independently associated with subclinical coronary atherosclerosis in healthy octogenarians. Aging Clin Exp Res. 2015 Feb;27(1):61-7. doi: 10.1007/s40520-014-0249-4. Epub 2014 Jun 7.

    PMID: 24906678BACKGROUND
  • Henriques AD, Tonet-Furioso AC, Machado-Silva W, Freitas WM, Quaglia LA, Santos SN, Cordova C, Sposito AC, Nobrega OT; Brazilian Study on Healthy Aging Group. Apoliprotein E genotype is associated with apoliprotein B plasma levels but not with coronary calcium score in very elderly individuals in primary care setting. Gene. 2014 Apr 15;539(2):275-8. doi: 10.1016/j.gene.2014.01.077. Epub 2014 Feb 12.

    PMID: 24530308BACKGROUND
  • Souza VC, Freitas WM, Quaglia LA, Santos SN, Cordova C, Sposito AC, Nobrega OT. Osteopontin in bone mineral density of very old Brazilians. J Bone Miner Metab. 2013 Jul;31(4):449-54. doi: 10.1007/s00774-013-0425-1. Epub 2013 Mar 21.

    PMID: 23515922BACKGROUND
  • 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: 22436606BACKGROUND
  • Freitas WM, Quaglia LA, Santos SN, Soares AA, Japiassu AV, Boaventura V, dos Santos Barros E, Cordova C, Nobrega OT, Sposito AC. Association of systemic inflammatory activity with coronary and carotid atherosclerosis in the very elderly. Atherosclerosis. 2011 May;216(1):212-6. doi: 10.1016/j.atherosclerosis.2011.01.040. Epub 2011 Feb 2.

    PMID: 21316055BACKGROUND
  • de Azevedo Filho ER, Koeche C, Bueno FF, de Toledo O, Alves VP, da Silva HS, Moraes CF, Freitas WM, Campos-Staffico AM, de Carvalho LSF. Unraveling the intertwined threads of insomnia and sarcopenia in cognitive and functional impairment in octogenarians. BMC Geriatr. 2025 Nov 7;25(1):868. doi: 10.1186/s12877-025-06398-3.

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Leukocyte DNA

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Andrei C Sposito, Ph.D.

    University of Campinas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 19, 2015

Study Start

December 1, 2008

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations