Coronary Artery DiseaseCAD-ManNCT00844220

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

A study testing CT/MR and Catheterization in people with Coronary Artery Disease, run by Charite University, Berlin, Germany 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

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. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: CT/MR and Catheterization
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 340 participants
Where: 1 siteGermany
Study dates: 18 Feb 2009to Oct 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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité
Berlin, 10117

Other trials in Germany

About this study

Conditions: Coronary Artery Disease
Being tested: CT/MR, Catheterization
Keywords: Suspected coronary artery disease
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT/MRProcedure or surgery
CT/MRI-directed clinical management strategy
CatheterizationProcedure or surgery
Standard clinical management directed by conventional coronary angiography

Study groups in NCT00844220
Study group	Role	What they receive
CT/MR	Experimental	CT/MRI-directed clinical management strategy Receives: Procedure: CT/MR
Catheterization	Active comparator	Standard clinical management Receives: Procedure: Catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: during or up to 2 days after procedures

Secondary outcomes (13)

Hard Cardiovascular Events
Composite endpoint: The most important secondary outcome will be hard cardiovascular events at final follow-up (3 years). These hard events include: cardiac and noncardiac death (death from any cause), stroke, and myocardial infarction. These hard events are considered as major adverse cardiovascular events.
Measured: Follow-up 3 (36-60 Months)
Comparison of Contrast Induced Nephropathy
To compare contrast-induced nephropathy (CIN) defined as increase in creatinine by 25% or 0.5 mg/dl from baseline at the measurements obtained 18 to 24 and/or 46 to 50 hours after the initial procedures as part of standard safety parameters performed at our institution. In addition, CIN will also be assessed during the follow-ups.
Measured: 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
To compare soft cardiovascular events (unstable angina pectoris, re-revascularization, and first revascularization at least 2 months after randomization, according to the results of Ladenheim et al. J Am Coll Cardiol 1986, at final follow-up.
Measured: Follow-up 3 (36-60, Months)
Comparison of In-Hospital Stay
to compare the in-hospital stay time and overall length of stay.
Measured: Up to 24 hours after the end of the in-hospital stay.
Quality of Life Analysis
To analyze the change in quality of life (QALY) in both groups (prior to the tests and at follow-up) using the SF-12 and the EuroQuol as general measurement tools and the MacNew questionnaire as disease-specific questionnaire.
Measured: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Confounding Effects of Nutrition, Physical Activity, and Depression
To analyze the effect and potentially confounding effect of nutrition, physical activity (using the Freiburg questionnaire), and depression (assessed with the HADS questionnaire) in the two groups.
Measured: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Comparison of Cost-effectiveness
To compare cost-effectiveness in both groups using the primary and secondary efficacy data, the QALY data, and cost data derived from the trial.
Measured: Follow-up 3 (36-60 Months)
Comparison of Patient Preference
To analyze patient preference and satisfaction with the therapeutic management strategies with a focus on the comfort during the imaging tests.
Measured: 24 hours after last procedure related to computed tomography or conventional coronary angiography
Comparison of the Amount of Contrast Agent
Comparison of the amount of contrast agent
Measured: 10 minutes after the examinations.
Comparison of the Amount of Radiation Exposure
10 minutes after computed tomography or conventional coronary angiography
Measured: Comparison of the amount of radiation exposure
Analysis of Image Quality
To analyze which image quality in multislice computed coronary angiography would be required to directly reliably triage patients to coronary artery bypass grafting.
Measured: Up to 24 hours after the end of computed tomography
Analysis of Correlation and Agreement About the Stenosis Diameter Between Multislice Computed Coronary Angiography and Conventional Coronary Angiography
To analyze the correlation and agreement between multislice computed coronary angiography and conventional coronary angiography (using quantitative analysis) for estimation of the percent diameter stenosis in patients who underwent both tests.
Measured: Up to 24 hours after the end of computed tomography
Comparison of Biological Effects of Radiation Exposure
To compare the biological effects of radiation exposure of ionizing radiation, measured by DNA double-strand breaks in lymphocytes, of CT and conventional coronary angiography themselves and in the two randomization groups (approval by ethics board for this substudy with start of first patient analyzed on September, 15, 2009). Blood samples are taken for double-strand break analysis.
Measured: Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 2009Oct 2018

First posted16 Feb 2009 (estimated)
Study start18 Feb 2009
Primary completionSep 2015
Study completionOct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00844220
Sponsor's protocol ID: EA1/080/08
Acronym: CAD-Man
Status last verified: Mar 2021
First submitted: 13 Feb 2009
Last updated: 15 Mar 2021
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 20234975
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.
PubMed 20725881
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.
PubMed 19704093
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.
PubMed 21273517
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.
PubMed 21232705
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.
PubMed 27777234
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.
PubMed 31864987
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.
PubMed 40411549
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.
PubMed 35090035
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.
PubMed 31264950

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
ClinicalTrials.gov ID: NCT00844220
Acronym / sponsor ID: CAD-Man / EA1/080/08
Conditions: Coronary Artery Disease
Keywords: Suspected coronary artery disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Collaborators: University Hospital Muenster, Charite University, Berlin, Eva Schönenberger, MD, University of Freiburg
Study start: 18 Feb 2009 (actual)
Primary completion: Sep 2015 (actual)
Study completion: Oct 2018 (actual)
First posted: 16 Feb 2009 (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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CT/MR	Experimental	Procedure: CT/MRCT/MRI-directed clinical management strategy
Catheterization	Active comparator	Procedure: CatheterizationStandard clinical management

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

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
CT/MRCT/MRI-directed clinical management strategy	Procedure or surgery	CT/MR
CatheterizationStandard clinical management directed by conventional coronary angiography	Procedure or surgery	Catheterization

Primary outcome

Complications
Time frame: during or up to 2 days after procedures
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).

13 secondary outcomes

Hard Cardiovascular Events
Time frame: Follow-up 3 (36-60 Months)
Comparison of Contrast Induced Nephropathy
Time frame: 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
Time frame: Follow-up 3 (36-60, Months)
Comparison of In-Hospital Stay
Time frame: Up to 24 hours after the end of the in-hospital stay.
Quality of Life Analysis
Time frame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Confounding Effects of Nutrition, Physical Activity, and Depression
Time frame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Comparison of Cost-effectiveness
Time frame: Follow-up 3 (36-60 Months)
Comparison of Patient Preference
Time frame: 24 hours after last procedure related to computed tomography or conventional coronary angiography
Comparison of the Amount of Contrast Agent
Time frame: 10 minutes after the examinations.
Comparison of the Amount of Radiation Exposure
Time frame: Comparison of the amount of radiation exposure
Analysis of Image Quality
Time frame: Up to 24 hours after the end of computed tomography
Analysis of Correlation and Agreement About the Stenosis Diameter Between Multislice Computed Coronary Angiography and Conventional Coronary Angiography
Time frame: Up to 24 hours after the end of computed tomography
Comparison of Biological Effects of Radiation Exposure
Time frame: Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam

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 15 Mar 2021.
Background: PubMed 20234975Dewey 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.
Background: PubMed 20725881Zimmermann 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.
Background: PubMed 19704093Dewey 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.
Background: PubMed 21273517Dewey 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.
Background: PubMed 21232705Schoenhagen 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.
Results publication: PubMed 27777234Dewey 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.
Results publication: PubMed 31864987Bosserdt 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.
Derived from this study: PubMed 40411549Bosserdt 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.
Derived from this study: PubMed 35090035Bosserdt 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.
Derived from this study: PubMed 31264950Schonenberger 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.
CAD-Man resultsLink provided by the sponsor.

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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.

Marc Dewey, MD, PhD principal investigator

Charite University, Berlin, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CT/MR and Catheterization in people with Coronary Artery Disease, run by Charite University, Berlin, Germany 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 4 inclusion and 4 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 15 Mar 2021. 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?

Complications (time frame: during or up to 2 days after procedures). 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 NCT00844220, which also lists 10 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 15 Mar 2021.