Clinical trial NCT00447148: Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison
Official title: Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Antwerp Cardiovascular Institute Middelheim
Sponsor class: OTHER
First posted: 2007-03-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: standard coronary angiography over/underestimates the length of the coronary segment evaluated.
timeFrame: peri-procedural
Secondary outcomes:
measure: 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.
measure: Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
measure: 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.
measure: 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.
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp Cardiovascular Institute Middelheim
Study officials:
affiliation: Antwerp Cardiovascular Institute Middelheim
name: Pierfrancesco Agostoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antwerp Cardiovascular Institute Middelheim
name: Stefan Verheye, MD, PhD
role: STUDY_CHAIR
affiliation: Antwerp Cardiovascular Institute Middelheim
name: Glenn Van Langenhove, MD, PhD
role: STUDY_DIRECTOR
References: