Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ventricular Volume as Assessed by Cardiac Magnetic Resonance

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.
 
ClinicalTrials.gov Identifier: NCT01678040
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Lars Grosse-Wortmann, The Hospital for Sick Children

Brief Summary:
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 or disease
Arrhythmogenic Right Ventricular Cardiomyophathy (ARVC)

Detailed Description:
  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.
  3. To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate.

Layout table for study information
Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI Assessment of the Effect of Preload on Ventricular Volumes and Function in Healthy Adult Volunteers
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : June 2013

Group/Cohort
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.



Primary Outcome Measures :
  1. 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 :
  1. 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.

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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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
Layout table for location information
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Layout table for investigator information
Principal Investigator: Lars Grosse-Wortmann, MD The Hospital for Sick Children
Layout table for additonal information
Responsible Party: Lars Grosse-Wortmann, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01678040    
Other Study ID Numbers: 1000031585
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Keywords provided by Lars Grosse-Wortmann, The Hospital for Sick Children:
Ventricular Volume
Cardiac Magnetic Resonance
Echocardiogram