Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging

NCT ID: NCT00844220

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-18

Study Completion Date

2018-10-31

Brief Summary

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The primary objective of this study is to analyze the clinical value of a therapeutic management strategy based on the results of coronary CT angiography and functional MRI. The clinical value of CT and MRI will be analyzed in patients with suspected coronary artery disease.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CT/MR

CT/MRI-directed clinical management strategy

Group Type EXPERIMENTAL

CT/MR

Intervention Type PROCEDURE

CT/MRI-directed clinical management strategy

Catheterization

Standard clinical management

Group Type ACTIVE_COMPARATOR

Catheterization

Intervention Type PROCEDURE

Standard clinical management directed by conventional coronary angiography

Interventions

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CT/MR

CT/MRI-directed clinical management strategy

Intervention Type PROCEDURE

Catheterization

Standard clinical management directed by conventional coronary angiography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Suspected coronary artery disease and planned conventional coronary angiography based on atypical angina pectoris

Exclusion Criteria

* Known coronary artery disease
* ST elevation
* Age below 30 years
* Women of child-bearing potential without a negative pregnancy test
* Inclusion in another study
* Heart rate above 70 beats per min and contraindications to beta blockers
* Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block
* Inability to hold the breath for 10 s
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role collaborator

Charite University, Berlin, Eva Schönenberger, MD

UNKNOWN

Sponsor Role collaborator

University of Freiburg

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Marc Dewey

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Dewey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité

Berlin, , Germany

Site Status

Countries

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Germany

References

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Dewey M, de Vries H, de Vries L, Haas D, Leidecker C. The present and future of cardiac CT in research and clinical practice: moderated discussion and scientific debate with representatives from the four main vendors. Rofo. 2010 Apr;182(4):313-21. doi: 10.1055/s-0029-1245195. Epub 2010 Mar 16.

Reference Type BACKGROUND
PMID: 20234975 (View on PubMed)

Zimmermann E, Dewey M. Whole-heart 320-row computed tomography: reduction of radiation dose via prior coronary calcium scanning. Rofo. 2011 Jan;183(1):54-9. doi: 10.1055/s-0029-1245629. Epub 2010 Aug 19.

Reference Type BACKGROUND
PMID: 20725881 (View on PubMed)

Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24.

Reference Type BACKGROUND
PMID: 19704093 (View on PubMed)

Dewey M. Coronary CT versus MR angiography: pro CT--the role of CT angiography. Radiology. 2011 Feb;258(2):329-39. doi: 10.1148/radiol.10100161. No abstract available.

Reference Type BACKGROUND
PMID: 21273517 (View on PubMed)

Schoenhagen P, Nagel E. Noninvasive assessment of coronary artery disease anatomy, physiology, and clinical outcome. JACC Cardiovasc Imaging. 2011 Jan;4(1):62-4. doi: 10.1016/j.jcmg.2010.11.002. No abstract available.

Reference Type BACKGROUND
PMID: 21232705 (View on PubMed)

Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.

Reference Type RESULT
PMID: 27777234 (View on PubMed)

Bosserdt M, Feger S, Rief M, Preuss D, Ibes P, Martus P, Kofoed KF, Laule M, Perez I, Dewey M. Performing Computed Tomography Instead of Invasive Coronary Angiography: Sex Effects in Patients With Suspected CAD. JACC Cardiovasc Imaging. 2020 Mar;13(3):888-889. doi: 10.1016/j.jcmg.2019.10.014. Epub 2019 Dec 18. No abstract available.

Reference Type RESULT
PMID: 31864987 (View on PubMed)

Bosserdt M, Mohamed M, Neumann K, Rieckmann N, Dreger H, Brodszky V, Hofer S, Reinhold T, Mielke AM, Dewey M. Cost-utility of computed tomography in patients with atypical chest pain clinically referred for invasive coronary angiography: randomised controlled trial. Eur Radiol. 2025 May 24. doi: 10.1007/s00330-025-11692-0. Online ahead of print.

Reference Type DERIVED
PMID: 40411549 (View on PubMed)

Bosserdt M, Martus P, Tauber R, Dreger H, Dewey M, Schonenberger E; CAD-Man Study Group Investigators. Serum creatinine baseline fluctuation and acute kidney injury after intravenous or intra-arterial contrast agent administration-an intraindividual comparison as part of a randomized controlled trial. Nephrol Dial Transplant. 2022 May 25;37(6):1191-1194. doi: 10.1093/ndt/gfac013. No abstract available.

Reference Type DERIVED
PMID: 35090035 (View on PubMed)

Schonenberger E, Martus P, Bosserdt M, Zimmermann E, Tauber R, Laule M, Dewey M. Kidney Injury after Intravenous versus Intra-arterial Contrast Agent in Patients Suspected of Having Coronary Artery Disease: A Randomized Trial. Radiology. 2019 Sep;292(3):664-672. doi: 10.1148/radiol.2019182220. Epub 2019 Jul 2.

Reference Type DERIVED
PMID: 31264950 (View on PubMed)

Related Links

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Other Identifiers

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EA1/080/08

Identifier Type: -

Identifier Source: org_study_id

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