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Completed

NCT Number: NCT01030549

Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study

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

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Campinas

Campinas, São Paulo, 13100, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2009
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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