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

NCT00447148 | Completed Phase 4

• 1 other identifier: ACIM 2006-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

  peri-procedural

Secondary Outcomes (4)

• 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.

Study Arms (1)

1

NO INTERVENTION

Paired comparison of 2 angiographic techniques

Procedure: 3-dimensional coronary angiography

Interventions

3-dimensional coronary angiography PROCEDURE

3-dimensional coronary angiography

Also known as: coronary angiography

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antwerp Cardiovascular Institute Middelheim: lead

Study Sites (1)

Antwerp Cardiovascular Institute Middelheim

Antwerp, 2020, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Pierfrancesco Agostoni, MD

  Antwerp Cardiovascular Institute Middelheim

  PRINCIPAL INVESTIGATOR

• Stefan Verheye, MD, PhD

  Antwerp Cardiovascular Institute Middelheim

  STUDY CHAIR

• Glenn Van Langenhove, MD, PhD

  Antwerp Cardiovascular Institute Middelheim

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 14, 2007
• Study Start: October 1, 2006
• Study Completion: July 1, 2007
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

BE (1)