HealthyNCT01030549
Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study
An observational study of Healthy, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Dec 2013
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal healthy individuals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Keywords
- cardiovascular magnetic resonance, ventricular volumes, ventricular function, Healthy normal individuals from 20 to 80 years of age
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment of patients (time zero). No follow-up will be performed since the trial is cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Juliano de Lara Fernandes, University of Campinas, Brazil
- Investigators
- Juliano L Fernandes, MD, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030549
- Sponsor's protocol ID
- CMRLAC-01
- Status last verified
- Jan 2015
- First submitted
- 9 Dec 2009
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study
- ClinicalTrials.gov ID
- NCT01030549
- Acronym / sponsor ID
- CMRLAC-01
- Conditions
- Healthy
- Keywords
- cardiovascular magnetic resonance, ventricular volumes, ventricular function, Healthy normal individuals from 20 to 80 years of age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Dec 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to investigate the physiological properties of adult heart using cardiovascular magnetic resonance imaging in normal volunteers in Latin America.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal healthy individuals
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliano L Fernandes, MD, PhD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Campinas, Brazil at 1 site 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 4 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 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2015.