Ignite Creation Date:
2024-05-06 @ 7:41 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02580851
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2015-10-14
Brief Title:
Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2018-05
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:
MAGnet
Brief Summary:
Current guidelines for the diagnosis and management of patients with stable coronary artery disease CAD strongly support the performance of non-invasive imaging techniques for the detection of myocardial ischemia prior to revascularization procedures This recommendation originates from the strong evidence base showing the lack of prognostic benefit from percutaneous coronary interventions PCI over optimal medical therapy in patients without verification of myocardial ischemia On the other hand it could be demonstrated that patients with functionally significant coronary artery stenoses do benefit from revascularization Cardiac magnetic resonance imaging CMR has emerged to be a diagnostic modality of choice for the detection of myocardial ischemia with high sensitivity and specificity The investigators therefore designed this prospective and randomized trial to compare a CMR-driven vs angiography-driven management of patients with stable CAD concerning major cardiac endpoints futile angiographies and quality of life
Detailed Description:
Current guidelines for the diagnosis and management of patients with stable coronary artery disease CAD recommend - besides thorough history and physical examination - proper risk stratification prior to invasive therapy The detection or exclusion of moderate to severe reversible myocardial ischemia is a crucial part of the work-up process which designates the patients to the high-risk group when ischemia is present This is of special interest as several observational studies have shown that the prognostic benefit from revascularization depends on the amount of myocardial ischemia Moreover patients without ischemia do not seem to benefit from revascularization over optimal medical therapy This emphasizes the need for functional testing prior to therapeutic decisions
Invasive coronary angiography still is considered to be the gold-standard for the diagnosis of CAD though it exhibits several limitations and shortcomings Multiple studies have documented the significant interobserver variability in the grading of coronary artery stenosis as well as the frequent occurrence of under- and overestimation of hemodynamic relevance One has to conclude that coronary angiography may provide anatomical information but is not the modality of choice concerning the detection of myocardial ischemia Moreover there is no study which has randomized patients with stable CAD to either catheterization or no catheterization yet so there does not exist high-quality evidence which would support the performance of a diagnostic coronary angiography in the majority of cases of stable CAD This is of special interest as there is a reported frequency of complications due to diagnostic coronary angiography of about 15 Nevertheless coronary angiography remains the most often performed diagnostic test in this setting with more than one-half of elective percutaneous coronary interventions PCI done without previous stress-testing
Adenosine perfusion cardiac magnetic resonance imaging CMR is an imaging modality which provides anatomical and functional information in one single examination With its ability to reliably detect reversible myocardial ischemia it plays an increasing role in the diagnosis and risk stratification of patients with suspected or known CAD Though CMR therefore is highly recommended in the diagnostic work-up in the setting of stable CAD no study exists which would have evaluated a CMR driven approach in patient management with regard to the occurrence of major cardiac events quality of life and safety endpoints
Objective of our study is to show that a CMR based conservative or invasive management of patients with suspected or known CAD is not inferior with regard to major cardiac endpoints and quality of life in comparison to a - more conventional - coronary angiography based approach The investigators assume that a significant number of diagnostic coronary angiographies and PCIs thus could be spared without decrease in patient safety and comfort
Invasive coronary angiography still is considered to be the gold-standard for the diagnosis of CAD though it exhibits several limitations and shortcomings Multiple studies have documented the significant interobserver variability in the grading of coronary artery stenosis as well as the frequent occurrence of under- and overestimation of hemodynamic relevance One has to conclude that coronary angiography may provide anatomical information but is not the modality of choice concerning the detection of myocardial ischemia Moreover there is no study which has randomized patients with stable CAD to either catheterization or no catheterization yet so there does not exist high-quality evidence which would support the performance of a diagnostic coronary angiography in the majority of cases of stable CAD This is of special interest as there is a reported frequency of complications due to diagnostic coronary angiography of about 15 Nevertheless coronary angiography remains the most often performed diagnostic test in this setting with more than one-half of elective percutaneous coronary interventions PCI done without previous stress-testing
Adenosine perfusion cardiac magnetic resonance imaging CMR is an imaging modality which provides anatomical and functional information in one single examination With its ability to reliably detect reversible myocardial ischemia it plays an increasing role in the diagnosis and risk stratification of patients with suspected or known CAD Though CMR therefore is highly recommended in the diagnostic work-up in the setting of stable CAD no study exists which would have evaluated a CMR driven approach in patient management with regard to the occurrence of major cardiac events quality of life and safety endpoints
Objective of our study is to show that a CMR based conservative or invasive management of patients with suspected or known CAD is not inferior with regard to major cardiac endpoints and quality of life in comparison to a - more conventional - coronary angiography based approach The investigators assume that a significant number of diagnostic coronary angiographies and PCIs thus could be spared without decrease in patient safety and comfort
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