Myocardial Deformation in Real-time 3D Ultrasound. Normal Values in Adults and Validation Against the Tagged MRI (DIRECT)

July 23, 2015 updated by: University Hospital, Caen

Cardiac exploration almost systematically requires the acquisition and / or calculating function indices. The ejection fraction (LVEF) is probably based index most widely used in all cardiac exploration methods. This relatively universal overall index has very many qualities. LVEF is widely used in clinical practice through the exploration and monitoring of all heart disease.

Current progress in the management of various cardiomyopathies pass through the detection of early attacks. This testing often takes place upstream changes in LVEF that remains long normal or normalized. Sensitive indicators capable of detecting early abnormalities of regional functions are essential in addition to conventional echocardiography. Various studies have shown the contribution of these new markers in early detection of abnormalities of the cardiac function. The most widely used indicator in these studies because of its high sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler however has limitations in particular its dependence on the incident angle, which makes it impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.

A new way of exploring the regional function of the heart, speckle tracking, can analyze heart deformations along the principal axes of the heart. The advantage of this technique has been shown in various pathological situations. Currently, this technique is mostly used in longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this technique is not currently known, acquisition of 3D technology is recent (2004) and dedicated software is confidential dissemination and unvalidated.

The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In the 90s, studies have demonstrated the feasibility of this technique, the ability to access all of the myocardial deformation in space and to define normal values. The cost of the procedure, duration, limited accessibility and post-processing very time consuming limited the scope of the clinical benefits of this modality.

Echocardiography has major advantages over MRI, particularly its high availability, low cost and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is a new opportunity that it is essential to validate.

The main purpose of the study is to compare the strain values obtained 3D ultrasound to those obtained by MRI tagged in a control group and a group of subjects with an anterior infarction sequela.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 14033
        • Recruiting
        • CAEN University Hospital
        • Contact:
          • Eric Saloux, MD
          • Phone Number: 0231065395
        • Principal Investigator:
          • Eric saloux, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who signed the consent form
  • Beneficiaries of the health security system
  • No known cardiovascular disease to healthy subjects or patient having a previous heart attack or less proved by cardiac MRI or viability of myocardial scintigraphy performed before. The infarct zone is defined as the area of delayed enhancement cardiac MRI signal in 10-15 minutes after gadolinium injection.

Exclusion Criteria:

  • Age <18 years
  • Adult guardianship
  • Contraindications to MRI: metallic implants, pacemaker, implantable defibrillator, claustrophobia
  • For patients only: Contraindication to Dotarem (renal failure with creatinine clearance <30 ml / min / 1.73m2 according to MDRD formula, known allergy to gadolinium salts)
  • Pregnant and or lactating
  • Recent acute coronary syndrome (<6 weeks)
  • Ventricular arrhythmias and supra ventricular significant
  • Heart failure stage III-IV NYHA
  • Unbalanced severe hypertension (BP> 160/110 mmHg)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy volunteers
Other: MRI
Other: 3D cardiac ultrasound
Other: Subjects with an anterior myocardial infarction sequela
Other: MRI
Other: 3D cardiac ultrasound
Other: Subjects with lower myocardial infarction sequelae
Other: MRI
Other: 3D cardiac ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strain value
Time Frame: baseline
Comparison beetween arms and taage MRI and 3D cardiac echography
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 27, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe