Arrhythmogenic Right Ventricular Cardiomyophathy (ARVC) Clinical Trial
Official title:
MRI Assessment of the Effect of Preload on Ventricular Volumes and Function in Healthy Adult Volunteers
| NCT number | NCT01678040 |
| Other study ID # | 1000031585 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2012 |
| Est. completion date | June 2013 |
| Verified date | July 2019 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | June 2013 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Hydration | To evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability. | Day 1 | |
| Secondary | Chamber Deformation | To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate | Day 1 |