NCT01030549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 5, 2015

Status Verified

January 1, 2015

Enrollment Period

4 years

First QC Date

December 9, 2009

Last Update Submit

January 2, 2015

Conditions

Healthy

Keywords

cardiovascular magnetic resonanceventricular volumesventricular functionHealthy normal individuals from 20 to 80 years of age

Outcome Measures

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.

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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal healthy individuals

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13100, Brazil

Location

Study Officials

  • Juliano L Fernandes, MD, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Reasearcher

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 11, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 5, 2015

Record last verified: 2015-01

Locations

BR(1)