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

This study has been completed.
Sponsor:
Collaborator:
Dept. of Radiology
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00921440
First received: June 15, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 15, 2009
Last Updated: June 15, 2009
Health Authority: Germany: Federal Agency for Radiation Protection

Keywords provided by University of Cologne:
coronary artery
stenosis

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

ClinicalTrials.gov processed this record on June 18, 2013