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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
3-dimensional coronary angiography
Sponsored by
Antwerp Cardiovascular Institute Middelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

  • 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.

Sites / Locations

  • Antwerp Cardiovascular Institute Middelheim

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

1

Arm Description

Paired comparison of 2 angiographic techniques

Outcomes

Primary Outcome Measures

standard coronary angiography over/underestimates the length of the coronary segment evaluated.

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.

Full Information

First Posted
March 13, 2007
Last Updated
October 29, 2007
Sponsor
Antwerp Cardiovascular Institute Middelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00447148
Brief Title
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison
Acronym
3-DCA
Official Title
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Antwerp Cardiovascular Institute Middelheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Paired comparison of 2 angiographic techniques
Intervention Type
Procedure
Intervention Name(s)
3-dimensional coronary angiography
Other Intervention Name(s)
coronary angiography
Intervention Description
3-dimensional coronary angiography
Primary Outcome Measure Information:
Title
standard coronary angiography over/underestimates the length of the coronary segment evaluated.
Time Frame
peri-procedural
Secondary Outcome Measure Information:
Title
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.
Title
Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierfrancesco Agostoni, MD
Organizational Affiliation
Antwerp Cardiovascular Institute Middelheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Verheye, MD, PhD
Organizational Affiliation
Antwerp Cardiovascular Institute Middelheim
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Glenn Van Langenhove, MD, PhD
Organizational Affiliation
Antwerp Cardiovascular Institute Middelheim
Official's Role
Study Director
Facility Information:
Facility Name
Antwerp Cardiovascular Institute Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium

12. IPD Sharing Statement

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

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