Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI (InfarctusGSI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02360150|
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Rouen.
Recruitment status was: Recruiting
First Posted : February 10, 2015
Last Update Posted : August 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Radiation: second propeller arm scanner||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
Experimental: 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.
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.
- Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT [ Time Frame: Day 4 ]To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.
- Number of patient with a possible evaluation of myocardial viability using cardiac MRI [ Time Frame: Day 4 ]To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360150
|Contact: Benjamin DUBOURG, Doctor||2 32 88 64 96 ext +33||Benjamin.Dubourg@chu-rouen.fr|
|Contact: Jérome CAUDRON, Doctor||2 32 88 64 96 ext +33||Jerome.Caudron@chu-rouen.fr|
|University Hospital of Rouen||Recruiting|
|Rouen, Normandie, France, 76031|
|Contact: Benjamin DUBOURG, Doctor 2 32 88 64 96 ext +33 Benjamin.Dubourg@chu-rouen.fr|
|Sub-Investigator: Jérome CAUDRON, Doctor|
|Principal Investigator:||Benjamin DUBOURG, Doctor||University Hospital, Rouen|
|Study Director:||Jean-Nicolas DACHER, Professor||University Hospital, Rouen|