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

Myocardial Infarction Clinical Trial

— InfarctusGSI  

Official title:

Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02360150
• Other study ID #: 2013/205/HP
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2014
• Last updated: August 16, 2016
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: August 2016
• Source: University Hospital, Rouen
• Contact: Benjamin DUBOURG, Doctor
• Phone: 2 32 88 64 96
• Email: Benjamin.Dubourg[@]chu-rouen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
France	University Hospital of Rouen	Rouen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT	To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.	Day 4	No
Secondary	Number of patient with a possible evaluation of myocardial viability using cardiac MRI	To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.	Day 4	No