Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Coronary Angiography
- Registration Number
- NCT01776866
- Lead Sponsor
- General Hospital of Chinese Armed Police Forces
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Age>18 years old, <80 years old
- a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Coronary Angiography 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).
- Primary Outcome Measures
Name Time Method Diagnosis of Coronary Heart Disease After coronary angiography, an expected average of 1 month 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%.
- Secondary Outcome Measures
Name Time Method Coronary Lesion Assessment After coronary angiography, an expected average of 1 month 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)
Diagnostic Screening Adequacy After coronary angiography, an expected average of 1 month 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.
Quantitative Coronary Angiography After coronary angiography, an expected average of 1 month 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.
Trial Locations
- Locations (1)
General hospital of Chinese people's armed police forces
🇨🇳Beijing, China