Clinical Trials Directory

Trials / Completed

CompletedNCT00447148

Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison

Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Antwerp Cardiovascular Institute Middelheim · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared with an "in-vivo" surrogate of the real length of the coronary segment under evaluation, i.e. an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1) the length of a coronary segment evaluated with a standard 2-dimensional "optimal view" over/underestimates the length assessed by a 3-dimensional coronary model that automatically detects the least foreshortened length of the segment under evaluation, and (2) the 3-dimensional model approximates more closely than standard 2-dimensional angiography, the real length of the segment detected by the marker guide-wire.

Detailed description

The potential to improve the accuracy of the assessment of the coronary tree by means of 3-D modeling reconstruction may lead to an evaluation of the coronary artery anatomy that approximates more correctly the real anatomy, thus subsequently leading to a more tailored diagnosis and therapy for the patients with ischemic heart disease. Aim of the current study is to assess whether a 3-D model of the coronary tree offers a less foreshortened and less operator-dependent evaluation of the length of the coronary arteries with respect to standard coronary angiography. Furthermore, for the first time "in-vivo", a comparison with the "real" length of the vessel will be performed using as "gold standard" an intra-coronary guide-wire with radiopaque markers at fixed and known distance one from the other along its distal part.

Conditions

Interventions

TypeNameDescription
PROCEDURE3-dimensional coronary angiography3-dimensional coronary angiography

Timeline

Start date
2006-10-01
Completion
2007-07-01
First posted
2007-03-14
Last updated
2007-10-31

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT00447148. Inclusion in this directory is not an endorsement.