Ventricular Volume as Assessed by Cardiac Magnetic Resonance

MRI Assessment of the Effect of Preload on Ventricular Volumes and Function in Healthy Adult Volunteers

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid Status	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydration	To evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability.	Day 1
Chamber Deformation	To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate	Day 1

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Lars Grosse-Wortmann, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Cardiac Magnetic Resonance; Echocardiogram; Ventricular Volume
• Other Study ID Numbers: 1000031585