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

Coronary Artery Disease Clinical Trial

— CAD-Man  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844220
• Other study ID #: EA1/080/08
• Status: Completed
• Phase: N/A
• Start date: February 18, 2009
• Est. completion date: October 2018

Study information

• Verified date: March 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: October 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• CT/MR
CT/MRI-directed clinical management strategy
• Catheterization
Standard clinical management directed by conventional coronary angiography

Locations

Country	Name	City	State
Germany	Charité	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Charite University, Berlin, Eva Schönenberger, MD, University Hospital Muenster, University of Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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- — View 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. — View Citation

Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Böhm M, Schlattmann P, Hamm B, Schönenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for i — View Citation

Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dübel 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Follow-up 3 (36-60 Months)
Secondary	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.	Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Secondary	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.	Follow-up 3 (36-60, Months)
Secondary	Comparison of In-Hospital Stay	to compare the in-hospital stay time and overall length of stay.	Up to 24 hours after the end of the in-hospital stay.
Secondary	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.	Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Secondary	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.	Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
Secondary	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.	Follow-up 3 (36-60 Months)
Secondary	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.	24 hours after last procedure related to computed tomography or conventional coronary angiography
Secondary	Comparison of the Amount of Contrast Agent	Comparison of the amount of contrast agent	10 minutes after the examinations.
Secondary	Comparison of the Amount of Radiation Exposure	10 minutes after computed tomography or conventional coronary angiography	Comparison of the amount of radiation exposure
Secondary	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.	Up to 24 hours after the end of computed tomography
Secondary	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.	Up to 24 hours after the end of computed tomography
Secondary	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.	Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam

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