Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447148
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2007-03-13
Brief Title:
Standard vs 3-Dimensional Coronary Angiography a Paired Comparison
Sponsor:
Antwerp Cardiovascular Institute Middelheim
Organization:
Antwerp Cardiovascular Institute Middelheim
Study Overview
Official Title:
Standard vs 3-Dimensional Coronary Angiography a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison Gold Standard
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3-DCA
Brief 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 overunderestimated 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 ie 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 overunderestimates 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None