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

General Hospital of Chinese Armed Police Forces

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary Angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT01776866

20130101 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Coronary Angiography

Other group

Description:

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).

Treatment:

Procedure: Coronary Angiography