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

Not Applicable

• Conditions: Myocardial Infarction

• Registration Number: NCT02360150
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Study First Submitted: 2014-12-15
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT	Day 4	To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.

Secondary Outcome Measures

Name	Time	Method
Number of patient with a possible evaluation of myocardial viability using cardiac MRI	Day 4	To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.

Trial Locations

Locations (1)

University Hospital of Rouen; 🇫🇷 Rouen, Normandie, France