Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI

NCT ID: NCT02360150

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-02-28

Brief Summary

The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.

This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.

Detailed Description

Percutaneous coronary intervention is not recommended in stable patients with late presentation myocardial infarction, and myocardial viability needs to be evaluated before the procedure. The aim of the study is to evaluate the sensibility and specificity of dual-energy CT for the evaluation of myocardial viability in comparison to cardiac MRI.

The experimental procedure is limited to a second CT acquisition performed 10 minutes in dual energy mode.

Sensitivity and Specificity of delayed enhancement >50% of myocardial thickness provided by dual-energy CT will be evaluated in comparison to cardiac MRI.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

second propeller arm scanner

The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement to the inclusion visit.

Group Type: EXPERIMENTAL

second propeller arm scanner

Intervention Type: RADIATION

The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement.

Interventions

second propeller arm scanner

The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Man or woman
• Major patient
• Patient with electrical, biological and clinical signs of myocardial infarction, with late presentation (>24 hours)
• Creatinine clearance (calculated using the Cockcroft (<age 65) or MDRD (> 65 years))formula > 30 ml / min.
• Affiliation to the french social security scheme.
• Women of childbearing age: Negative pregnancy test (urine test).
• Postmenopausal women, menopause confirmation of diagnosis
• Patient able to understand the spoken and written French.
• Signature of informed consent

Exclusion Criteria

• Collapsus or organ failure requiring urgent care in intensive care unit
• Arrhythmia and/or non-reducible tachycardia.
• History of allergic reaction after iodinated contrast medium injection.
• History of nephrogenic systemic fibrosis.
• History of claustrophobia
• Unbalanced asthma.
• Acute pulmonary edema.
• Pregnant or breastfeeding women.
• Clinical signs of thyrotoxicosis.
• Person placed under judicial protection,
• Patient suffering from serious psychiatric disease.
• Patients participating in another clinical trial.
• Contraindication to MRI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin DUBOURG, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Jean-Nicolas DACHER, Professor

Role: STUDY_DIRECTOR

University Hospital, Rouen

Locations

University Hospital of Rouen

Rouen, Normandy, France

Site Status: RECRUITING

Countries

France

Central Contacts

Benjamin DUBOURG, Doctor

Role: CONTACT

Benjamin.Dubourg@chu-rouen.fr

2 32 88 64 96 ext. +33

Jérome CAUDRON, Doctor

Role: CONTACT

Jerome.Caudron@chu-rouen.fr

2 32 88 64 96 ext. +33

Facility Contacts

Benjamin DUBOURG, Doctor

Role: primary

Benjamin.Dubourg@chu-rouen.fr

2 32 88 64 96 ext. +33

Other Identifiers

2013/205/HP

Identifier Type: -

Identifier Source: org_study_id