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Computed Tomography Coronary Angiography (CTCA) and Coronary Flow in Stenosis Analysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921440
First Posted: June 16, 2009
Last Update Posted: June 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dept. of Radiology
Information provided by:
University of Cologne
  Purpose
The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate measurement of computed tomographic changes in coronary artery flow profiles and whether CT flow measurements are suitable for classifying the significance and hemodynamic relevance of a stenosis and thereby supplement as a functional parameter for morphological stenosis analysis.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CT Coronary Angiography: Coronary Flow Quantification Supplements Morphological Stenosis Analysis

Further study details as provided by University of Cologne:

Enrollment: 50
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:
A total of 50 patients prospectively underwent computed tomography coronary angiography (CTCA) in a multidetector CT scanner (Brilliance 64, Philips) ± 1 day before or after invasive coronary angiography (ICA). Immediately thereafter, 2 radiologists reviewed the imaging data to detect any vessel segments with morphology poorly evaluable by CTCA. A locally constant cyclical measurement was acquired in these coronary arteries in breath-hold technique during the passage of a 50ml bolus of contrast media. For analysis, time-density curves of the bolus passage were registered in the coronary artery and the aorta (internal reference), the up-slopes were determined and correlated with each other. The results were compared with the ICA findings.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
people with suspected or known coronary artery disease (CAD)
Criteria

Inclusion Criteria:

  • Clinically known or presumed CAD
  • Age > 50 years
  • Hospitalization for invasive coronary angiography
  • Sinus rhythm
  • Written informed consent by the patient to participate in the study after comprehensive presentation of the facts

Exclusion Criteria:

  • Age <= 50 years
  • Contraindications to contrast media administration (medical history of iodine allergy, nephropathy, latent or manifest hyperthyroidism)
  • Arrhythmias
  • Dyspnea at rest, acute unstable angina pectoris, acute myocardial infarction
  • Pregnancy
  • Implanted pacemaker
  • Unwillingness of patient to consent to the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921440


Sponsors and Collaborators
University of Cologne
Dept. of Radiology
Investigators
Principal Investigator: Barbara Krug, Prof. Dr. Dept. of Radiology, University Hospital of Cologne
  More Information

Responsible Party: Prof. Dr. med. Barbara Krug, University Hospital of Cologne, Dept. Radiology
ClinicalTrials.gov Identifier: NCT00921440     History of Changes
Other Study ID Numbers: 22462/2 - 2005-070
First Submitted: June 15, 2009
First Posted: June 16, 2009
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by University of Cologne:
coronary artery
stenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical