Viewing Study NCT02360150


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Study NCT ID: NCT02360150
Status: UNKNOWN
Last Update Posted: 2016-08-17
First Post: 2014-12-15
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI
Sponsor: University Hospital, Rouen
Organization:

Study Overview

Official Title: Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.
Status: UNKNOWN
Status Verified Date: 2016-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: InfarctusGSI
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: