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Completed

NCT Number: NCT00447148

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antwerp Cardiovascular Institute Middelheim

Antwerp, 2020, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3-dimensional coronary angiography

Procedure

3-dimensional coronary angiography

Other names: coronary angiography

Primary outcomes

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

    Time frame: peri-procedural

Secondary outcomes

  1. 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.

  2. Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Antwerp Cardiovascular Institute Middelheim

Other

Registry information

Official study title

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

Acronym: 3-DCA

Important dates

Study start
2006
Study completion
2007
First posted
Mar 14, 2007
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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