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

Coronary Artery Disease Clinical Trial

Official title:

CT Coronary Angiography: Coronary Flow Quantification Supplements Morphological Stenosis Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921440
• Other study ID #: 22462/2 - 2005-070
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: June 15, 2009
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2009
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Agency for Radiation Protection
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Dept. of Radiology