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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Germany1 site
  • University of Ulm

    Ulm, 89081

Other trials in Germany

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.

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 groups in NCT02580851
Study groupRoleWhat they receive
Coronary angiographyOtherPatients 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 imagingOtherPatients 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.

  1. Number of cardiac deaths and non-fatal myocardial infarctions occurring in study cohort assessed by medical records

    Measured: 3 years

Secondary outcomes (2)
  1. Number of invasive procedures

    Diagnostic coronary angiographies/PCIs

    Measured: 3 years

  2. 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.

  1. First posted20 Oct 2015 (estimated)
  2. Study startDec 2011
  3. Primary completionJan 2018
  4. Study completionFeb 2018

Resources

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)
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 29976305
  • 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.

    PubMed 28754155

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.

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