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

March 11, 2021 updated by: Marc Dewey, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT/MR
CT/MRI-directed clinical management strategy
Procedure: CT/MR
CT/MRI-directed clinical management strategy
Active Comparator: Catheterization
Standard clinical management
Procedure: Catheterization
Standard clinical management directed by conventional coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
during or up to 2 days after procedures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hard Cardiovascular Events
Time Frame: Follow-up 3 (36-60 Months)
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)
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)
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)
Comparison of Comparison of Soft Cardiovascular Events
Time Frame: Follow-up 3 (36-60, Months)
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)
Comparison of In-Hospital Stay
Time Frame: Up to 24 hours after the end of the 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.
Quality of Life Analysis
Time Frame: Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months)
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)
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)
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)
Comparison of Cost-effectiveness
Time Frame: Follow-up 3 (36-60 Months)
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)
Comparison of Patient Preference
Time Frame: 24 hours after last procedure related to computed tomography or conventional coronary angiography
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
Comparison of the Amount of Contrast Agent
Time Frame: 10 minutes after the examinations.
Comparison of the amount of contrast agent
10 minutes after the examinations.
Comparison of the Amount of Radiation Exposure
Time Frame: Comparison of the amount of radiation exposure
10 minutes after computed tomography or conventional coronary angiography
Comparison of the amount of radiation exposure
Analysis of Image Quality
Time Frame: Up to 24 hours after the end of computed tomography
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
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
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
Comparison of Biological Effects of Radiation Exposure
Time Frame: Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

University Hospital Muenster
University of Freiburg
Charite University, Berlin, Eva Schönenberger, MD

Investigators

  • Principal Investigator: Marc Dewey, MD, PhD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2009

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (Estimate)

February 16, 2009

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/080/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on CT/MR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe