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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: 3-dimensional coronary angiography

• Registration Number: NCT00447148
• Lead Sponsor: Antwerp Cardiovascular Institute Middelheim

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 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-14
• Study Completion: 2007-07
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-29
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Clinical

• Age > 18 years.

• Ability to give informed consent.

• Clinical evidence of coronary artery disease:

  • recent (< 72 hours) acute myocardial infarction,
  • stable angina with documented positive stress test,
  • unstable angina with documented ischemia (positive ECG or troponin test or documented positive stress test).

Angiographic

• Eligibility for PCI in at least one de-novo stenosis in a native coronary artery, after the index angiogram.
• Planned PCI according to a previous coronary angiogram.

Exclusion Criteria

Clinical

• Pregnancy.
• Chronic or acute renal failure (serum creatinine > 1.8 mg/dL or hemodialysis).
• Urgent procedure (a procedure carried out before the next referring day, for example for acute myocardial infarction, unstable angina refractory to medical therapy or cardiogenic shock).
• Contraindications or known hypersensitivity to contrast media.
• Enrollment in another study protocol.

Angiographic

• Significant left main coronary artery disease.
• PCI for a total occlusion of a major coronary vessel (LAD, LCX or RCA).
• Extensive thrombotic burden in a coronary lesion (thrombus grade 3/4).
• TIMI flow <3 distal to the lesion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	3-dimensional coronary angiography	Paired comparison of 2 angiographic techniques

Primary Outcome Measures

Name	Time	Method
standard coronary angiography over/underestimates the length of the coronary segment evaluated.	peri-procedural

Secondary Outcome Measures

Name	Time	Method
The length of the segments, evaluated with standard and 3-D angiography, will be compared with the length of the segment measured with the marker guide-wire.
Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
All the QCA results of standard angiography will be compared with those of 3-D angiography, in particular in the segments where the lesion is.
The percentage of vessel foreshortening of the standard angiography operator-selected "working view" will be compared to the least foreshortened view automatically selected with the 3-D angiography reconstruction.

Trial Locations

Locations (1)

Antwerp Cardiovascular Institute Middelheim; 🇧🇪 Antwerp, Belgium