Stable Coronary Artery DiseaseMAGnetNCT02580851
Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
A study testing diagnostic test - cardiac magnetic resonance imaging and diagnostic test - coronary angiography in people with Stable Coronary Artery Disease and Cardiac Magnetic Resonance Imaging, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease, Cardiac Magnetic Resonance Imaging, Coronary Angiography
- What is being tested?
- diagnostic test - cardiac magnetic resonance imaging and diagnostic test - coronary angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present themselves for the evaluation of symptoms being likely to be caused by CAD, such as exercise-related chest pain or dyspnea.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stable Coronary Artery Disease, Cardiac Magnetic Resonance Imaging, Coronary Angiography, Myocardial Revascularization, Outcomes and Prognosis, Quality of Life
- Being tested
- diagnostic test - cardiac magnetic resonance imaging, diagnostic test - coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic test - cardiac magnetic resonance imagingOther
diagnostic test - coronary angiographyOther
| Study group | Role | What they receive |
|---|---|---|
| Coronary angiography | Other | 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. Receives: Other: diagnostic test - coronary angiography |
| Cardiac magnetic resonance imaging | Other | 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. Receives: Other: diagnostic test - cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cardiac deaths and non-fatal myocardial infarctions occurring in study cohort assessed by medical records
Measured: 3 years
Secondary outcomes (2)
Number of invasive procedures
Diagnostic coronary angiographies/PCIs
Measured: 3 years
Quality of life
Assessed by Seattle Angina Questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startDec 2011
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dominik Buckert, University of Ulm
- Investigators
- Peter Bernhardt, Prof. Dr., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580851
- Sponsor's protocol ID
- 237/11
- Acronym
- MAGnet
- Status last verified
- May 2018
- First submitted
- 14 Oct 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29976305Buckert 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.
PubMed 28754155
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
- ClinicalTrials.gov ID
- NCT02580851
- Acronym / sponsor ID
- MAGnet / 237/11
- Conditions
- Stable Coronary Artery Disease, Cardiac Magnetic Resonance Imaging, Coronary Angiography, Myocardial Revascularization, Outcomes and Prognosis, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary angiography | Other | Other: diagnostic test - coronary angiographyPatients 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. |
| Cardiac magnetic resonance imaging | Other | Other: diagnostic test - cardiac magnetic resonance imagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who present themselves for the evaluation of symptoms being likely to be caused by CAD, such as exercise-related chest pain or dyspnea.
Key exclusion criteria (8 listed)
- Unability to give written informed consent
- Unstable angina
- Cardiac or respiratory instability
- Contraindication for CMR
- Allergy to Gadolinium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic test - cardiac magnetic resonance imaging | Other | Cardiac magnetic resonance imaging |
| diagnostic test - coronary angiography | Other | Coronary angiography |
Primary outcome
Number of cardiac deaths and non-fatal myocardial infarctions occurring in study cohort assessed by medical records
Time frame: 3 years
2 secondary outcomes
Number of invasive procedures
Time frame: 3 years
Quality of life
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 29976305Buckert 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.
- Derived from this study: PubMed 28754155Buckert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bernhardt, Prof. Dr. principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic test - cardiac magnetic resonance imaging and diagnostic test - coronary angiography in people with Stable Coronary Artery Disease and Cardiac Magnetic Resonance Imaging, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cardiac deaths and non-fatal myocardial infarctions occurring in study cohort assessed by medical records (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580851, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.