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HealthyBSHANCT02366104

Brasília Study on Healthy Aging

An observational study of Healthy, run by University of Campinas, Brazil at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 80 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
230 participants
Where
2 sitesBrazil
Study dates
Dec 2008to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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.

Who may be able to join

  • Aged of 80 years or over

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Biocárdios - Instituto de Cardiologia

    Brasília, Federal District

  • University of Campinas

    Campinas, São Paulo, 13083-887

Other trials in Brazil

About this study

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.

Read the detailed description

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. Enrolled participants underwent a detailed clinical examination, including assessment of anthropometric measures, quality of life by the WHOQOL-BREF, psychological test by Geriatric Depression Scale (GDS) and cognitive function by the mini-mental state examination (MMSE). After 12h of overnight fasting, the study participants underwent to blood sampling collection for biochemical analysis and freezing of plasma, serum and DNA. Immediately after blood collection, participants underwent to cardiovascular ultrasound evaluations and computed tomography (CT) scans during the week following the initial assessment. After baseline measurements, all participants were referred to the study as outpatient clinic for prospective medical follow-up evaluations.

Anthropometric measures: body weight, height, waist circumference and skinfold thickness (triceps, biceps, suprailiac and subscapular) were measured. Body mass index (BMI) was calculated. Skinfold thickness was the mean of triplicate measurements at the right side, using a skinfold caliper (WCS Plus®, Cardiomed, Curitiba, Brazil).

Biochemical analysis: After collection, EDTA blood was centrifuged at 5 ◦ C, 4500 rpm for 15min to separate plasma and carrying out the following measurements: glucose (Glucose GOD-PAP, Roche Diagnostics, Mannheim, USA), total cholesterol (CHOD-PAP, Roche Diagnostics, Mannheim, USA), triglycerides (GPO-PAP, Roche Diagnostics, Mannheim, USA), HDL-C (HDL cholesterol without pretreatment, Roche Diagnostics, Mannheim, USA), C-reactive protein (highly sensitive, CardioPhase, Dade Behring, Marburg, USA), urea and creatinine (GLDH, Hitachi, Tokyo, Japan), fibrinogen (Sysmex CA 1500, Siemens, Munich, Germany), interleukin (IL) 10 and tumor necrosis factor type alpha (TNF-alpha) (eBioscience, San Diego, CA, USA). Parathyroid hormone (PTH) and calcitonin (Immulite 2000, Siemens, Los Angeles, CA, USA), bone fraction of alkaline phosphatase (Hitachi Autoanalyzer, Tokyo Japan), calcium (Hitachi Autoanalyzer, Tokyo, Japan), apoA and apoB (Behring Nephelometer BNII, Dade Behring, Marburg, Germany) were also measured.

Carotid ultrasound: The evaluation of intima-media thickness (IMT) and presence of carotid plaques were assessed using high-resolution B-mode ultrasound (Philips, model IE 33, 3-9 MHz linear transducer, Philips Medical Systems, Andover, MA, USA) according to the protocols of the American Association of Echocardiography. Bilateral measurements were made at the posterior wall of the bulb of the common carotid artery and at the internal carotid artery through a program of automatic edge detection (QLAB version 6.0 software). Carotid plaque was defined as the presence of focal thickening of at least 50% higher than surrounding areas or as focal region with IMT > 1.5 mm and distinct adjacent edges.

Cardiac computed tomography: Computed tomography was performed in a 64-slice scanner (Aquillion 64, Toshiba, Ottawara, Japan). Axial slices of 3 mm thickness with 3 mm table-feed were acquired at 70% of R-R interval with prospective ECG triggering. Coronary artery calcification was defined as a minimum of 3 contiguous pixels with a peak Hounsfield unit density > 130. Coronary artery calcifications were scored by a certified radiologist. The Agatston score was used to express the value of CAC.

Conditions
Healthy
Keywords
Cardiovascular Diseases, Aged, Primary Prevention
Medical subject headings
Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2015 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366104
Sponsor's protocol ID
Gerus
Acronym
BSHA
Status last verified
Mar 2019
First submitted
11 Feb 2015
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24906678

  • 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.

    PubMed 24530308

  • 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.

    PubMed 23515922

  • 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.

    PubMed 22436606

  • 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.

    PubMed 21316055

  • 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.

    PubMed 41204176

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by University of Campinas, Brazil at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02366104, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.

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