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

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
3D cardiac ultrasound
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Healthy volunteers

Subjects with an anterior myocardial infarction sequela

Subjects with lower myocardial infarction sequelae

Arm Description

Healthy volunteers

Subjects with an anterior myocardial infarction sequela

Subjects with lower myocardial infarction sequelae

Outcomes

Primary Outcome Measures

Strain value
Comparison beetween arms and taage MRI and 3D cardiac echography

Secondary Outcome Measures

Full Information

First Posted
July 23, 2015
Last Updated
July 23, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02508727
Brief Title
Myocardial Deformation in Real-time 3D Ultrasound. Normal Values in Adults and Validation Against the Tagged MRI
Acronym
DIRECT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers
Arm Title
Subjects with an anterior myocardial infarction sequela
Arm Type
Other
Arm Description
Subjects with an anterior myocardial infarction sequela
Arm Title
Subjects with lower myocardial infarction sequelae
Arm Type
Other
Arm Description
Subjects with lower myocardial infarction sequelae
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Type
Other
Intervention Name(s)
3D cardiac ultrasound
Primary Outcome Measure Information:
Title
Strain value
Description
Comparison beetween arms and taage MRI and 3D cardiac echography
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Caen University Hospital
City
Caen
State/Province
Basse Normandie
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Saloux, MD
Phone
0231065395
First Name & Middle Initial & Last Name & Degree
Eric saloux, MD

12. IPD Sharing Statement

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

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