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Clinical Trials/NCT01678040
NCT01678040
Completed
Not Applicable

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

The Hospital for Sick Children1 site in 1 country15 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmogenic Right Ventricular Cardiomyophathy (ARVC)
Sponsor
The Hospital for Sick Children
Enrollment
15
Locations
1
Primary Endpoint
Fluid Status
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
June 2013
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lars Grosse-Wortmann

Staff Cardiologist

The Hospital for Sick Children

Eligibility 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.

Outcomes

Primary Outcomes

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

  • Hydration(Day 1)
  • Chamber Deformation(Day 1)

Study Sites (1)

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