Clinical trial NCT01776866: Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography
Official title: Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Angiography
Rotational Coronary Angiography
Contrast Media
Radiation
Quantitative Coronary Angiography
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of Coronary Heart Disease
timeFrame: After coronary angiography, an expected average of 1 month
Secondary outcomes:
measure: Coronary Lesion Assessment
timeFrame: After coronary angiography, an expected average of 1 month
measure: Quantitative Coronary Angiography
timeFrame: After coronary angiography, an expected average of 1 month
measure: Diagnostic Screening Adequacy
timeFrame: After coronary angiography, an expected average of 1 month
Other outcomes:
measure: Safety Analysis
timeFrame: During coronary angiography
Locations:
city: Beijing
country: China
facility: General hospital of Chinese people's armed police forces
Study officials:
affiliation: General hospital of Chinese people's armed police forces
name: Liu Huiliang, M.D.
role: STUDY_CHAIR
affiliation: General hospital of Chinese people's armed police forces
name: Jin Zhigeng, M.M.
role: STUDY_DIRECTOR
affiliation: General hospital of Chinese people's armed police forces
name: Yang Shengli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Chinese people's armed police forces
name: Luo Jianping, M.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Chinese people's armed police forces
name: Ma Dongxing, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Chinese people's armed police forces
name: Liu Ying, M.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Chinese people's armed police forces
name: Han Wei, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Chinese people's armed police forces
name: Jing Limin, B.S.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia JA, Agostoni P, Green NE, Maddux JT, Chen SY, Messenger JC, Casserly IP, Hansgen A, Wink O, Movassaghi B, Groves BM, Van Den Heuvel P, Verheye S, Van Langenhove G, Vermeersch P, Van den Branden F, Yeghiazarians Y, Michaels AD, Carroll JD. Rotational vs. standard coronary angiography: an image content analysis. Catheter Cardiovasc Interv. 2009 May 1;73(6):753-61. doi: 10.1002/ccd.21918.
citation: Klein AJ, Garcia JA, Hudson PA, Kim MS, Messenger JC, Casserly IP, Wink O, Hattler B, Tsai TT, Chen SY, Hansgen A, Carroll JD. Safety and efficacy of dual-axis rotational coronary angiography vs. standard coronary angiography. Catheter Cardiovasc Interv. 2011 May 1;77(6):820-7. doi: 10.1002/ccd.22804. Epub 2011 Mar 11.
citation: Liu HL, Jin ZG, Yang SL, Luo JP, Ma DX, Liu Y, Han W. Randomized study on the safety and efficacy of dual-axis rotational versus standard coronary angiography in. Chin Med J (Engl). 2012 Mar;125(6):1016-22.
citation: Jin ZG, Bai R, Li Y, Yang Y, Han W, Zhao Q, Zhang L, Liu HL. Comparison of diagnostic accuracy of dual-axis rotational versus standard coronary angiography. Int J Cardiovasc Imaging. 2020 Feb;36(2):187-195. doi: 10.1007/s10554-019-01711-9. Epub 2019 Oct 18.