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

Study Overview
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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.

Official Title
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Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary Angiography


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Coronary Angiography<br>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). | Procedure: Coronary Angiography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Coronary Heart Disease | The number of patients diagnosed as coronary heart disease by either angiographic modality by two blinded independent reviewers are recorded. The single criterion for diagnosis of coronary heart disease is the presence of coronary artery stenoses greater than or equal to 50%. | After coronary angiography, an expected average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary Lesion Assessment | The number of lesions greater than or equal to 50% detected by either angiographic modality by two blinded independent reviewers are recorded. In addition, they are asked to comment on the characteristics of the greater than or equal to 50% lesions (number of coronary lesions, number of bifurcation lesions, location of lesion, multivessel disease, American College of Cardiology (ACC) lesion classification and Medina classification for bifurcation lesions) | After coronary angiography, an expected average of 1 month | 
| Quantitative Coronary Angiography | The quantitative coronary angiography analysis of the more than or equal to 50% lesions detected by the lesion assessment of either reviewer one or reviewer two in both angiographic modalities (lesion length, minimum lumen diameter, diameter stenosis). Quantitative coronary angiography analysis will be performed by the third different blinded, independent, reviewer. | After coronary angiography, an expected average of 1 month | 
| Diagnostic Screening Adequacy | Two different experienced reviewers analyzed the angiographic sets based on a Likert Scale for each vessel segment, calcification, thrombolysis in myocardial infarction (TIMI) flow, collaterals, displaying the lesions and bifurcations. | After coronary angiography, an expected average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Angiography, Rotational Coronary Angiography, Contrast Media, Radiation, Quantitative Coronary Angiography