NCT02580851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

6.1 years

First QC Date

October 14, 2015

Last Update Submit

May 1, 2018

Conditions

Stable Coronary Artery DiseaseCardiac Magnetic Resonance ImagingCoronary AngiographyMyocardial RevascularizationOutcomes and PrognosisQuality of Life

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (2)

  • Number of invasive procedures

    3 years

  • Quality of life

    3 years

Study Arms (2)

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.

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.

Other: diagnostic test - cardiac magnetic resonance imaging

Interventions

diagnostic test - cardiac magnetic resonance imagingOTHER
Cardiac magnetic resonance imaging
diagnostic test - coronary angiographyOTHER
Coronary angiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who present themselves for the evaluation of symptoms being likely to be caused by CAD, such as exercise-related chest pain or dyspnea.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm

Ulm, 89081, Germany

Location

Related Publications (2)

  • 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.

    PMID: 29976305DERIVED

  • 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.

    PMID: 28754155DERIVED

Study Officials

  • Peter Bernhardt, Prof. Dr.

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 20, 2015

Study Start

December 1, 2011

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

DE(1)