Coronary Artery Disease
Conditions
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.
Interventions
PROCEDURE3-dimensional coronary angiography
3-dimensional coronary angiography
Sponsors
Antwerp Cardiovascular Institute Middelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| standard coronary angiography over/underestimates the length of the coronary segment evaluated. | peri-procedural |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium
Outcome results
None listed