Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03231189
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2017-06-27
Brief Title:
Cardiac MRI in Front Line for the Diagnosis of Coronary Artery Disease As the Etiology of Left Ventricular Dysfunction
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prospective Multicentric Study for the Diagnostic Performance of CArdiac MAgnetic REsonance Imaging Used First for the Diagnosis of Coronary Artery Disease As the Etiology of Left Ventricular Dysfunction
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
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:
CAMAREC
Brief Summary:
When a patient is newly diagnosed of systolic dysfunction without obvious etiology such as rhythmic ischemic or valvular disease most of the time a coronary angiography is performed In this situation the investigators aim to evaluate a strategy with CMR as the front line exam and invasive coronary angiography performed only in case of ischemic scar on CMR Additionally a secondary analysis of the collected CMR images will be performed by the MIRACLAI core lab AP-HP Paris using artificial intelligence AI algorithms This analysis aims to enhance the diagnostic accuracy of coronary artery disease CAD detection in patients with reduced left ventricular ejection fraction rLVEF
Detailed Description:
Reduced Left Ventricular Ejection Fraction LVEF is estimated to be present in 3-7 of the population With a survival rate between 25-40 at 5 years after a first hospitalization prognosis of heart failure is similar to that of most cancers Its treatment and prognosis strongly depend on the etiology and coronary artery disease is the most frequent one Identifying coronary artery disease determines care including medical treatment aspirin statins and revascularization strategies stent implantation coronary artery bypass grafting Once an echocardiography has revealed an LV reduction with no clear etiology at clinical or echographical examination coronary angiography is almost systematically performed But among the 260000 invasive coronary angiographies performed each year in France all indications included 30-60 are normal no obstructive coronary artery
And among patients with unexplained LV dysfunction this rate reaches 70-74 Thus the efficiency of systematic coronary angiography is questionable for these latter Besides angiography is invasive and associated with multiple risks and costs
Cardiac Magnetic Resonance Imaging CMR is very specific and sensitive for detecting myocardial infarction Small series concluded that a reduction of LVEF due to coronary artery stenosis should have at least one myocardial scar detected on CMR But the available data was not enough to change guidelines and clinical practice In our retrospective study performed on 305 patients the sensibility of CMR for coronary stenosis was 96 Furthermore CMR as a first-line exam would have avoided 71 of coronary angiography saving 216 days of hospitalization and 329054 1079patient These results reinforce the previous data but are not definitive
The aim of this study is to provide a high level of evidence of the benefits and safety of a strategy based on CMR as the front line exam for newly diagnosed systolic dysfunctions
The primary objective is to evaluate the sensitivity of CMR for predicting the presence of angiographically significant coronary artery stenosis in patients with reduced LVEF The primary endpoint is the sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF
The objective of the economic evaluation is to estimate the incremental or decremental cost effectiveness of using CMR first compared to coronary angiography first
As part of the secondary analysis CMR images from the CAMAREC study will be transferred to the Multimodality Imaging for Research and Analysis Core Laboratory for Artificial Intelligence MIRACLAI at AP-HP Paris The MIRACLAI team led by Dr Theo Pezel will apply advanced AI algorithms to detect ischemic patterns and quantify myocardial scarring This AI analysis aims to improve the sensitivity and specificity of CMR in identifying significant CAD and non-ischemic cardiomyopathies
For unexplained LV dysfunction patient will be addressed for CMR first and coronary angiography within 2 weeks after instead of systematic coronary angiography and unsystematic CMR CMR and coronary angiography will be performed in all patients Independent committees will blindly review CMRs and coronary angiographies at the end of the study
Data from the CAMAREC study will be securely transferred to MIRACLAI for AI-based analysis This transfer does not affect the data flow to Lariboisière nor the confidentiality or the study39s timeline MIRACLAI will solely focus on the AI-enhanced interpretation of the CMR images
And among patients with unexplained LV dysfunction this rate reaches 70-74 Thus the efficiency of systematic coronary angiography is questionable for these latter Besides angiography is invasive and associated with multiple risks and costs
Cardiac Magnetic Resonance Imaging CMR is very specific and sensitive for detecting myocardial infarction Small series concluded that a reduction of LVEF due to coronary artery stenosis should have at least one myocardial scar detected on CMR But the available data was not enough to change guidelines and clinical practice In our retrospective study performed on 305 patients the sensibility of CMR for coronary stenosis was 96 Furthermore CMR as a first-line exam would have avoided 71 of coronary angiography saving 216 days of hospitalization and 329054 1079patient These results reinforce the previous data but are not definitive
The aim of this study is to provide a high level of evidence of the benefits and safety of a strategy based on CMR as the front line exam for newly diagnosed systolic dysfunctions
The primary objective is to evaluate the sensitivity of CMR for predicting the presence of angiographically significant coronary artery stenosis in patients with reduced LVEF The primary endpoint is the sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF
The objective of the economic evaluation is to estimate the incremental or decremental cost effectiveness of using CMR first compared to coronary angiography first
As part of the secondary analysis CMR images from the CAMAREC study will be transferred to the Multimodality Imaging for Research and Analysis Core Laboratory for Artificial Intelligence MIRACLAI at AP-HP Paris The MIRACLAI team led by Dr Theo Pezel will apply advanced AI algorithms to detect ischemic patterns and quantify myocardial scarring This AI analysis aims to improve the sensitivity and specificity of CMR in identifying significant CAD and non-ischemic cardiomyopathies
For unexplained LV dysfunction patient will be addressed for CMR first and coronary angiography within 2 weeks after instead of systematic coronary angiography and unsystematic CMR CMR and coronary angiography will be performed in all patients Independent committees will blindly review CMRs and coronary angiographies at the end of the study
Data from the CAMAREC study will be securely transferred to MIRACLAI for AI-based analysis This transfer does not affect the data flow to Lariboisière nor the confidentiality or the study39s timeline MIRACLAI will solely focus on the AI-enhanced interpretation of the CMR images
Study Oversight
Has Oversight DMC:
None
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?:
None