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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014