NCT02326701

Brief Summary

Echocardiographic assessment of right ventricular function is an important diagnostic tool, and is a challenge due to the unique structure and anatomy of the right ventricle. Lately a new technique has been developed and used for evaluating both the left and the right ventricle function. This technique, called two dimensional (2D) speckle tracking, is based on detecting speckles in the myocardial tissue and using them as acoustic markers. The movement of these speckles represents the movement of the tissue, and allows us to evaluate its function, contraction and relaxation, this by calculating the strain rate, which is the speed of the speckles, and the strain, which is the distance between them. In the last few years this technique has been used to evaluate the systolic function of the right ventricle in several pathological conditions, such as pulmonary hypertension, pulmonary embolism and amyloidosis. Nonetheless, so far there has been little data on the normal RV strain and strain rate values. In this study the investigators aim to validate two dimensional (2D) speckle tracking measurements of the RV function by comparing them to strain measurements by cardiac MRI. Each patient performing cardiac MRI for any indication will perform an echocardiography examination in addition, and strain analysis performed on the cardiac MRI will be compared with two dimensional speckle tracking analysis performed on the echocardiography.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

December 29, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

November 2, 2014

Last Update Submit

December 22, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation of 2D Echo and Echo strain measurements versus MRI measurements

    RV dimensions, RV function, RV strain measurements compared to MRI measurements

    1 year

Secondary Outcomes (1)

  • Rehospitalization

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients performing MRI for any indication

You may qualify if:

  • Age: More than 18

You may not qualify if:

  • Age: Children
  • Unconcious patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2014

First Posted

December 29, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Last Updated

December 29, 2014

Record last verified: 2014-10

Locations