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

Antwerp Cardiovascular Institute Middelheim

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Procedure: 3-dimensional coronary angiography

Study type

Interventional

Funder types

Other

Identifiers

NCT00447148

ACIM 2006-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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