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Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging (CAD-Man)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CT/MR
Catheterization
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Suspected coronary artery disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT/MR

Catheterization

Arm Description

CT/MRI-directed clinical management strategy

Standard clinical management

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
Comparison of In-Hospital Stay
to compare the in-hospital stay time and overall length of 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.
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.
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.
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.
Comparison of the Amount of Contrast Agent
Comparison of the amount of contrast agent
Comparison of the Amount of Radiation Exposure
10 minutes after computed tomography or conventional coronary angiography
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.
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.
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.

Full Information

First Posted
February 13, 2009
Last Updated
March 11, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
University Hospital Muenster, Charite University, Berlin, Eva Schönenberger, MD, University of Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT00844220
Brief Title
Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
Acronym
CAD-Man
Official Title
Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2009 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
University Hospital Muenster, Charite University, Berlin, Eva Schönenberger, MD, University of Freiburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Suspected coronary artery disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT/MR
Arm Type
Experimental
Arm Description
CT/MRI-directed clinical management strategy
Arm Title
Catheterization
Arm Type
Active Comparator
Arm Description
Standard clinical management
Intervention Type
Procedure
Intervention Name(s)
CT/MR
Intervention Description
CT/MRI-directed clinical management strategy
Intervention Type
Procedure
Intervention Name(s)
Catheterization
Intervention Description
Standard clinical management directed by conventional coronary angiography
Primary Outcome Measure Information:
Title
Complications
Description
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).
Time Frame
during or up to 2 days after procedures
Secondary Outcome Measure Information:
Title
Hard Cardiovascular Events
Description
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.
Time Frame
Follow-up 3 (36-60 Months)
Title
Comparison of Contrast Induced Nephropathy
Description
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.
Time Frame
Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Title
Comparison of Comparison of Soft Cardiovascular Events
Description
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.
Time Frame
Follow-up 3 (36-60, Months)
Title
Comparison of In-Hospital Stay
Description
to compare the in-hospital stay time and overall length of stay.
Time Frame
Up to 24 hours after the end of the in-hospital stay.
Title
Quality of Life Analysis
Description
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.
Time Frame
Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Title
Confounding Effects of Nutrition, Physical Activity, and Depression
Description
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.
Time Frame
Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Title
Comparison of Cost-effectiveness
Description
To compare cost-effectiveness in both groups using the primary and secondary efficacy data, the QALY data, and cost data derived from the trial.
Time Frame
Follow-up 3 (36-60 Months)
Title
Comparison of Patient Preference
Description
To analyze patient preference and satisfaction with the therapeutic management strategies with a focus on the comfort during the imaging tests.
Time Frame
24 hours after last procedure related to computed tomography or conventional coronary angiography
Title
Comparison of the Amount of Contrast Agent
Description
Comparison of the amount of contrast agent
Time Frame
10 minutes after the examinations.
Title
Comparison of the Amount of Radiation Exposure
Description
10 minutes after computed tomography or conventional coronary angiography
Time Frame
Comparison of the amount of radiation exposure
Title
Analysis of Image Quality
Description
To analyze which image quality in multislice computed coronary angiography would be required to directly reliably triage patients to coronary artery bypass grafting.
Time Frame
Up to 24 hours after the end of computed tomography
Title
Analysis of Correlation and Agreement About the Stenosis Diameter Between Multislice Computed Coronary Angiography and Conventional Coronary Angiography
Description
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.
Time Frame
Up to 24 hours after the end of computed tomography
Title
Comparison of Biological Effects of Radiation Exposure
Description
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.
Time Frame
Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Dewey, MD, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20234975
Citation
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.
Results Reference
background
PubMed Identifier
20725881
Citation
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.
Results Reference
background
PubMed Identifier
19704093
Citation
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.
Results Reference
background
PubMed Identifier
21273517
Citation
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.
Results Reference
background
PubMed Identifier
21232705
Citation
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.
Results Reference
background
PubMed Identifier
27777234
Citation
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. Erratum In: BMJ. 2016 Nov 29;355:i6420.
Results Reference
result
PubMed Identifier
31864987
Citation
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.
Results Reference
result
PubMed Identifier
35090035
Citation
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.
Results Reference
derived
PubMed Identifier
31264950
Citation
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.
Results Reference
derived
Links:
URL
http://www.bmj.com/content/355/bmj.i5441
Description
CAD-Man results

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

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