NCT00844220

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable coronary-artery-disease

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

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

February 18, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

6.5 years

First QC Date

February 13, 2009

Last Update Submit

March 11, 2021

Conditions

Coronary Artery Disease

Keywords

Suspected coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Complications

    Death, stroke, and myocardial infarction and moderate to severe groin hematoma, groin pain, infections, allergies, thromboses, and arteriovenous fistula or other complications (if prolonging the in-hospital stay significantly by at least 24 hours).

    during or up to 2 days after procedures

Secondary Outcomes (13)

  • Hard Cardiovascular Events

    Follow-up 3 (36-60 Months)

  • Comparison of Contrast Induced Nephropathy

    Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)

  • Comparison of Comparison of Soft Cardiovascular Events

    Follow-up 3 (36-60, Months)

  • Comparison of In-Hospital Stay

    Up to 24 hours after the end of the in-hospital stay.

  • Quality of Life Analysis

    Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)

  • +8 more secondary outcomes

Study Arms (2)

CT/MR

EXPERIMENTAL

CT/MRI-directed clinical management strategy

Procedure: CT/MR

Catheterization

ACTIVE COMPARATOR

Standard clinical management

Procedure: Catheterization

Interventions

CT/MRPROCEDURE

CT/MRI-directed clinical management strategy

CT/MR
CatheterizationPROCEDURE

Standard clinical management directed by conventional coronary angiography

Catheterization

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known coronary artery disease
  • ST elevation
  • Age below 30 years
  • Women of child-bearing potential without a negative pregnancy test
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, 10117, Germany

Location

Related Publications (10)

  • 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.

    PMID: 20234975BACKGROUND

  • 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.

    PMID: 20725881BACKGROUND

  • 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.

    PMID: 19704093BACKGROUND

  • 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.

    PMID: 21273517BACKGROUND

  • 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.

    PMID: 21232705BACKGROUND

  • 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.

    PMID: 27777234RESULT

  • 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.

    PMID: 31864987RESULT

  • 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 Nov;35(11):6719-6734. doi: 10.1007/s00330-025-11692-0. Epub 2025 May 24.

    PMID: 40411549DERIVED

  • 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.

    PMID: 35090035DERIVED

  • 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.

    PMID: 31264950DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Marc Dewey, MD, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

February 18, 2009

Primary Completion

September 1, 2015

Study Completion

October 1, 2018

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

DE(1)