Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030549
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : January 5, 2015
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Juliano de Lara Fernandes, University of Campinas, Brazil

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

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study
Study Start Date : December 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Primary Outcome Measures :
  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 ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030549

University of Campinas
Campinas, SP, Brazil, 13100
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Juliano L Fernandes, MD, PhD University of Campinas, Brazil

Responsible Party: Juliano de Lara Fernandes, Physician Reasearcher, University of Campinas, Brazil Identifier: NCT01030549     History of Changes
Other Study ID Numbers: CMRLAC-01
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

Keywords provided by Juliano de Lara Fernandes, University of Campinas, Brazil:
cardiovascular magnetic resonance
ventricular volumes
ventricular function
Healthy normal individuals from 20 to 80 years of age