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Ventricular Volume as Assessed by Cardiac Magnetic Resonance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by The Hospital for Sick Children.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01678040
First Posted: September 3, 2012
Last Update Posted: September 3, 2012
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.
Information provided by (Responsible Party):
The Hospital for Sick Children
  Purpose
One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right ventricular (RV) volumes. There are a number of congenital heart defects and acquired conditions in which management decisions are fundamentally based on ventricular volumes. The "gold standard" for assessment of RV volume is CMR. It has better near-field resolution than echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable to the irregular geometry of the RV. The objectives of this study are (1) to assess ventricular volumes in the fasting state and after oral hydration in order to assess the effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate. This study hypothesizes that (1) hydration status has an effect on right and left heart volumes, measured by CMR in healthy volunteers; (2) the effect of volume status will be a more significant contributor to variability in RV volumetry than that of inter-observer variability and intra-observer variability, and; (3) atrial and Ventricular deformation corrected for chamber size or volume is more accurate than when uncorrected for volume.

Condition
Ventricular Volume

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI Assessment of the Effect of Preload on Ventricular Volumes and Function in Healthy Adult Volunteers

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Fluid Status [ Time Frame: Day 1 ]
    To assess ventricular volumes in the fasting state and after oral hydration in order to assess the effect of fluid status on ventricular volumes as measured by CMR.


Secondary Outcome Measures:
  • Hydration [ Time Frame: Day 1 ]
    To evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability.

  • Chamber Deformation [ Time Frame: Day 1 ]
    To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate


Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac Magnetic Resonance
The CMR examinations will be performed in the cardiac MRI scanner (Siemens "Avanto", 1.5 Tesla, Erlangen, Germany) at the Hospital for Sick Children. A brief echocardiogram will be performed using a GE Vivid 7 or Vivid E9 machine (General Electric Medical Systems, Wisconsin, USA) We will image from standard parasternal long axis and apical four-chamber before and after completed hydration.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Staff from the Heart Centre at The Hospital for Sick Children will be sent an email notifying them of the study. They will be invited to obtain the particulars of the study by replying to Dr. Daryl Schantz or Dr. Lars Grosse-Wortmann. If they agree to participate Dr. Schantz will obtain written informed consent.
Criteria

Inclusion Criteria:

  • Participant must be healthy

Exclusion Criteria:

  • Individuals who are unable to participate in an overnight fast will be excluded
  • Those with known or suspected structural heart disease will be excluded
  • A screening form to identify pre-existing cardiac conditions will be completed by the subject prior to participation in this study. If a pre-existing condition cardiac condition is identified, or suspected they will be excluded from the study.
  • If any functional abnormality is detected at any stage by echocardiography or by CMR the study will be terminated. Common anatomical variants, which are generally regarded as normal variants (such as a patent foramen ovale, or a persistent left superior vena cava) will not lead to exclusion from the study.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01678040


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Lars Grosse-Wortmann, MD The Hospital for Sick Children
  More Information

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01678040     History of Changes
Other Study ID Numbers: 1000031585
First Submitted: August 30, 2012
First Posted: September 3, 2012
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by The Hospital for Sick Children:
Ventricular Volume
Cardiac Magnetic Resonance
Echocardiogram