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

This study has been completed.
Sponsor:
Information provided by:
Antwerp Cardiovascular Institute Middelheim
ClinicalTrials.gov Identifier:
NCT00447148
First received: March 13, 2007
Last updated: October 29, 2007
Last verified: October 2007

March 13, 2007
October 29, 2007
October 2006
Not Provided
standard coronary angiography over/underestimates the length of the coronary segment evaluated. [ Time Frame: peri-procedural ]
  • HA: standard coronary angiography over/underestimates the length of the coronary segment evaluated.
  • H0: no difference in segment length evaluation between standard and 3-D angiography.
Complete list of historical versions of study NCT00447148 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
Procedure: 3-dimensional coronary angiography
3-dimensional coronary angiography
Other Name: coronary angiography
No Intervention: 1
Paired comparison of 2 angiographic techniques
Intervention: Procedure: 3-dimensional coronary angiography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00447148
ACIM 2006-001
No
Not Provided
Antwerp Cardiovascular Institute Middelheim
Not Provided
Principal Investigator: Pierfrancesco Agostoni, MD Antwerp Cardiovascular Institute Middelheim
Study Chair: Stefan Verheye, MD, PhD Antwerp Cardiovascular Institute Middelheim
Study Director: Glenn Van Langenhove, MD, PhD Antwerp Cardiovascular Institute Middelheim
Antwerp Cardiovascular Institute Middelheim
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP