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

Sponsored by:	Antwerp Cardiovascular Institute Middelheim
Information provided by:	Antwerp Cardiovascular Institute Middelheim
ClinicalTrials.gov Identifier:	NCT00447148

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 IV

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"

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
1: No Intervention Paired comparison of 2 angiographic techniques	Procedure: 3-dimensional coronary angiography 3-dimensional 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

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009