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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: 3-dimensional coronary angiography
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"

Resource links provided by NLM:


Further study details as provided by Antwerp Cardiovascular Institute Middelheim:

Primary Outcome Measures:
  • standard coronary angiography over/underestimates the length of the coronary segment evaluated. [ Time Frame: peri-procedural ]

Secondary Outcome Measures:
  • 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.

Enrollment: 36
Study Start Date: October 2006
Study Completion Date: July 2007
Arms Assigned Interventions
No Intervention: 1
Paired comparison of 2 angiographic techniques
Procedure: 3-dimensional coronary angiography
3-dimensional coronary angiography
Other Name: coronary angiography

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447148

Locations
Belgium
Antwerp Cardiovascular Institute Middelheim
Antwerp, Belgium, 2020
Sponsors and Collaborators
Antwerp Cardiovascular Institute Middelheim
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447148     History of Changes
Other Study ID Numbers: ACIM 2006-001
Study First Received: March 13, 2007
Last Updated: October 29, 2007
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 20, 2014