Coronary Artery Disease
Conditions
Keywords
Coronary Angiography, Rotational Coronary Angiography, Contrast Media, Radiation, Quantitative Coronary Angiography
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.
Interventions
PROCEDURECoronary 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.
Sponsors
General Hospital of Chinese Armed Police Forces
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Analysis | During coronary angiography | The time(seconds), contrast usage(ml) and radiation dose(Gycm2) are recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The time, contrast and radiation to perform isocentering are included during dura-axis rotational coronary angiography. The time, contrast and radiation to engage the coronary ostium, exchange catheters, and perform non-coronary angiography are excluded from the analysis. All adverse events observed by the operator or reported by the patient are recorded. |
Countries
China
Outcome results
None listed