Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Campinas, Brazil.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01030549
First received: December 9, 2009
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

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


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal healthy individuals

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030549

Contacts
Contact: Juliano L Fernandes, MD, PhD +55-19-37592903 jlaraf@fcm.unicamp.br

Locations
Brazil
University of Campinas Recruiting
Campinas, SP, Brazil, 13100
Contact: Juliano L Fernandes, MD, PhD    +55-19-35792903    jlaraf@fcm.unicamp.br   
Principal Investigator: Juliano L Fernandes, MD, PhD         
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Juliano L Fernandes, MD, PhD University of Campinas, Brazil
  More Information

No publications provided

Responsible Party: Juliano de Lara Fernandes, University of Campinas
ClinicalTrials.gov Identifier: NCT01030549     History of Changes
Other Study ID Numbers: CMRLAC-01
Study First Received: December 9, 2009
Last Updated: January 18, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on July 26, 2014