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

Coronary Artery Disease Clinical Trial

— 3-DCA  

Official title:

Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447148
• Other study ID #: ACIM 2006-001
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2007
• Last updated: October 29, 2007
• Start date: October 2006
• Est. completion date: July 2007

Study information

• Verified date: October 2007
• Source: Antwerp Cardiovascular Institute Middelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• 3-dimensional coronary angiography
3-dimensional coronary angiography

Locations

Country	Name	City	State
Belgium	Antwerp Cardiovascular Institute Middelheim	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Antwerp Cardiovascular Institute Middelheim

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	standard coronary angiography over/underestimates the length of the coronary segment evaluated.		peri-procedural
Secondary	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.
Secondary	Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
Secondary	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.
Secondary	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.