Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-05-31

Brief Summary

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The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.

Detailed Description

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The prior studies have demonstrated that dual-axis rotational coronary angiography (DARCA) is associated with lower contrast usage and radiation exposure compared with standard coronary angiography (SA). Single-axis rotational coronary angiography (RA) has been proved by previous studies without any reduction in diagnostic accuracy compared to SA. However, the rotational protocol is obvious different between DARCA and single-axis RA. A recent study has assessed the diagnostic accuracy of DARCA, but this study was not designed for image content analysis and the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The diagnostic accuracy of DARCA aroused our attention.

Conditions

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Coronary Artery Disease

Keywords

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Coronary Angiography Rotational Coronary Angiography Contrast Media Radiation Quantitative Coronary Angiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Coronary Angiography

Patient first undergo standard coronary angiography(SA) of either left or right coronary system followed by dual-axis rotational coronary angiography(DARCA). The SA protocol consist of six different projections (right anterior oblique (RAO)-caudal, RAO-cranial (CRA), left anterior oblique (LAO)-CRA, LAO-caudal (CAU), antero-posterior (AP)-CRA and AP-CAU) for left coronary artery (LCA) and two projections (LAO and AP-cranial) for right coronary artery (RCA).

The DARCA protocol consist of two coronary acquisitions specified by the protocol: one for LCA (Swing LCA CRA 35 5.8s), another for RCA (Swing RCA AP 4.0s).

Group Type OTHER

Coronary Angiography

Intervention Type PROCEDURE

Coronary angiography include standard coronary angiography (SA) and dual-axis rotational coronary angiography (DARCA). Patient first undergo SA of either left or right coronary system followed by DARCA.

Interventions

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Coronary Angiography

Coronary angiography include standard coronary angiography (SA) and dual-axis rotational coronary angiography (DARCA). Patient first undergo SA of either left or right coronary system followed by DARCA.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age\>18 years old, \<80 years old
* a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease

Exclusion Criteria

* Pregnancy
* Known allergy to iodinated contrast
* Patients who had received iodinated contrast material within the last week or were unable to give consent
* Renal insufficiency (\>1.5mg/dL)
* Acute myocardial infarction within one week
* Cardiogenic shock
* heart function worse than New York Heart Association functional class III
* Left main coronary artery disease
* Prior coronary artery bypass graft treatment
* Prior percutaneous coronary intervention treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR