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

Myocardial Infarction Clinical Trial

— DIRECT  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02508727
• Other study ID #: 10-156
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2015
• Last updated: July 23, 2015
• Start date: March 2012

Study information

• Verified date: July 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Myocardial Infarction

Intervention

Other:
• MRI

• 3D cardiac ultrasound

Locations

Country	Name	City	State
France	Caen University Hospital	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strain value	Comparison beetween arms and taage MRI and 3D cardiac echography	baseline	No