RV Function Evaluation Assessed by Strain and Validated by MRI

Right Ventricular Function Clinical Trial

Official title:

RV Function by Strain and MRI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02326701
• Other study ID #: DG001-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2014
• Last updated: December 22, 2014
• Start date: December 2014

Study information

• Verified date: October 2014
• Source: Hadassah Medical Organization
• Contact: Ronen Beeri, MD
• Phone: 00972508573400
• Email: rbeeri[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health - Director GeneralIsrael: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: More than 18

Exclusion Criteria:

• Age: Children

• Unconcious patients.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Right Ventricular Function

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of 2D Echo and Echo strain measurements versus MRI measurements	RV dimensions, RV function, RV strain measurements compared to MRI measurements	1 year	No
Secondary	Rehospitalization	Time from index event to timing and length of rehospitalization (based on hospital data and completed with phone interview when necessary)	2 years	No