Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention (MAGnet)
Primary Purpose
Stable Coronary Artery Disease, Cardiac Magnetic Resonance Imaging, Coronary Angiography
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
diagnostic test - cardiac magnetic resonance imaging
diagnostic test - coronary angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Stable Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patients who present themselves for the evaluation of symptoms being likely to be caused by CAD, such as exercise-related chest pain or dyspnea.
Exclusion Criteria:
- Unability to give written informed consent
- Unstable angina
- Cardiac or respiratory instability
- Contraindication for CMR
- Allergy to Gadolinium
- Impaired renal function
- Allergy to adenosine
- Pregnancy
Sites / Locations
- University of Ulm
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Coronary angiography
Cardiac magnetic resonance imaging
Arm Description
Patients directly undergo diagnostic coronary angiography. A PCI is performed according to current guidelines in case of ≥70% stenosis in a coronary vessel with ≥2 mm diameter.
Patients receive adenosine perfusion CMR for functional testing, first. The examination is conducted on a 3.0 Tesla whole-body scanner with a 32-channel phased-array cardiac receiver coil according to a well-established standard protocol [21-23]. In case reversible ischemia can be detected, subjects are sent to coronary angiography and PCI afterwards.
Outcomes
Primary Outcome Measures
Number of cardiac deaths and non-fatal myocardial infarctions occurring in study cohort assessed by medical records
Secondary Outcome Measures
Number of invasive procedures
Diagnostic coronary angiographies/PCIs
Quality of life
Assessed by Seattle Angina Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02580851
Brief Title
Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
Acronym
MAGnet
Official Title
Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 1.5%. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease, Cardiac Magnetic Resonance Imaging, Coronary Angiography, Myocardial Revascularization, Outcomes and Prognosis, Quality of Life
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronary angiography
Arm Type
Other
Arm Description
Patients directly undergo diagnostic coronary angiography. A PCI is performed according to current guidelines in case of ≥70% stenosis in a coronary vessel with ≥2 mm diameter.
Arm Title
Cardiac magnetic resonance imaging
Arm Type
Other
Arm Description
Patients receive adenosine perfusion CMR for functional testing, first. The examination is conducted on a 3.0 Tesla whole-body scanner with a 32-channel phased-array cardiac receiver coil according to a well-established standard protocol [21-23]. In case reversible ischemia can be detected, subjects are sent to coronary angiography and PCI afterwards.
Intervention Type
Other
Intervention Name(s)
diagnostic test - cardiac magnetic resonance imaging
Intervention Type
Other
Intervention Name(s)
diagnostic test - coronary angiography
Primary Outcome Measure Information:
Title
Number of cardiac deaths and non-fatal myocardial infarctions occurring in study cohort assessed by medical records
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of invasive procedures
Description
Diagnostic coronary angiographies/PCIs
Time Frame
3 years
Title
Quality of life
Description
Assessed by Seattle Angina Questionnaire
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who present themselves for the evaluation of symptoms being likely to be caused by CAD, such as exercise-related chest pain or dyspnea.
Exclusion Criteria:
Unability to give written informed consent
Unstable angina
Cardiac or respiratory instability
Contraindication for CMR
Allergy to Gadolinium
Impaired renal function
Allergy to adenosine
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bernhardt, Prof. Dr.
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29976305
Citation
Buckert D, Witzel S, Steinacker JM, Rottbauer W, Bernhardt P. Comparing Cardiac Magnetic Resonance-Guided Versus Angiography-Guided Treatment of Patients With Stable Coronary Artery Disease: Results From a Prospective Randomized Controlled Trial. JACC Cardiovasc Imaging. 2018 Jul;11(7):987-996. doi: 10.1016/j.jcmg.2018.05.007.
Results Reference
derived
PubMed Identifier
28754155
Citation
Buckert D, Witzel S, Cieslik M, Tibi R, Rottbauer W, Bernhardt P. Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial. Trials. 2017 Jul 28;18(1):358. doi: 10.1186/s13063-017-2101-6.
Results Reference
derived
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Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
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