CClinicalTrials.gg
CompletedNCT01030549Updated Jan 5, 2015

Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study

An observational study in Healthy, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-05.

Sponsored by University of Campinas, Brazil · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
300
Ages
20 Years to 80 Years
Sex
All
01

Study summary

This study was designed to investigate the physiological properties of adult heart using cardiovascular magnetic resonance imaging in normal volunteers in Latin America.

Read the detailed description

Evaluation of myocardial mass, volumes and function is essential in the management of cardiovascular diseases. While 2D and 3D echocardiography play a major role in determining these parameters cardiovascular magnetic resonance (CMR) has become a widely accepted gold standard for these measurements due to its high accuracy and reproducibility.

However, determining normal reference standards for CMR is crucial for proper use of the method. Previous reports have established normal ranges for both fast low angle shot techniques6 and the more commonly used steady state free precession methods including values normalized not only to body surface area but to age and gender as well. Despite these general references, variability in normal ranges have been reported previously when ethnicity is taken into account. The ongoing Multi-Ethnic Study of Atherosclerosis (MESA) trial has measured cardiovascular function in participants with different ethnical backgrounds, reporting differences in the African-American and Asian-American groups.

Latin-American populations have generally been underrepresented in most clinical cardiovascular trials despite representing a growing percentage of heart disease patients in the world and, particularly, in the USA12-15. While the MESA trial evaluated cardiac function by CMR in Hispanics, data was limited to participants living in USA, within a restricted age group and representing only a small fraction of their entire cohort. It is thus essential to acquire specific data for this population regarding normal CMR values in order to permit not only precise clinical evaluation of Hispanic patients but also accurate assessment of ventricular function figures from Latin American countries in future CMR and drug trials.

To accomplish this goal, we propose a multicenter study to collect CMR data from countries in Latin America in normal participants with 20-80 years of age.

02

Conditions studied

  • Healthy

Keywords

  • cardiovascular magnetic resonance
  • ventricular volumes
  • ventricular function
  • Healthy normal individuals from 20 to 80 years of age
03

In context

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Normal healthy individuals

Inclusion criteria

  • Asymptomatic subjects with 20 to 80 years of age with no history of cardiac disease, no known risk factors with normal physical examination and ECG

Exclusion criteria

Exclusion Criteria:

  • Current smokers or smokers with \< 10 years of quitting
  • Systolic blood pressure > 120mmHg or diastolic blood pressure > 80mmHg
  • Fasting blood glucose > 100mg/dL
  • Total cholesterol > 240mg/dL
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
300 participants (actual)
06

What researchers measure

Primary outcomes

  1. CMR data: end-diastolic volume, end-systolic volume, stroke volume, cardiac output, ejection fraction, mass, ascending and descending aortic diameters, aortic arch diameter, atrial diameter, interventricular septum thickness, posterior wall thickness.

    Time frame: At enrollment of patients (time zero). No follow-up will be performed since the trial is cross-sectional

07

Study locations

1 site
  • University of Campinas
    Campinas, SP 13100, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01030549
Lead sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Juliano de Lara Fernandes (Physician Reasearcher, University of Campinas, Brazil) — Principal investigator
First posted
Dec 11, 2009
Start date
Dec 2009
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jan 5, 2015

Study contacts

Juliano L Fernandes, MD, PhD
principal investigator · University of Campinas, Brazil

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion