Skip to main content
OpenTrials
Completed

NCT Number: NCT01678040

Ventricular Volume as Assessed by Cardiac Magnetic Resonance

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrhythmogenic Right Ventricular Cardiomyophathy (ARVC)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

  • 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.
  • To evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability.
  • To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 3, 2012
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.