Clinical trial NCT01625533: Safety and Efficacy Study of Dual-axis Rotational Versus Standard Coronary Angiography
Official title: Randomized Study on the Safety and Efficacy of Dual-axis Rotational Versus Standard Coronary Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Angiography
Rotational Coronary Angiography
Contrast media
Radiation
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing diagnostic coronary angiography at the General Hospital of Chinese People's Armed Police Forces.

Brief summary: The purpose of this study is to assess the clinical safety and efficacy of dual-axis rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by directly comparing it to standard coronary angiography (SA).

Detailed description: Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). The risk of complications from the contrast agent (such as discomfort, warmth, pain, hypotension and bradycardia) is increased with the use of DARCA. It remains to be evaluated whether this approach is also suitable for coronary angiography, especially using in the patients with complex coronary lesions. Previous studies revealed promising results, but the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The purpose of this study is to evaluate the feasibility, safety, clinical tolerance, and hemodynamic effect of DARCA in comparison to the well-established SA.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* A clinical indication for diagnostic coronary angiography to evaluate possible CAD

Exclusion Criteria:

* Pregnancy
* Known allergy to iodinated contrast
* Renal insufficiency (\>1.5mg/dL)
* Cardiogenic shock
* Acute myocardial infarction within one week
* Prior coronary artery bypass graft treatment
* Prior percutaneous coronary intervention treatment

Primary outcomes:
measure: Clinical safety of the patient during coronary angiography(CA)
timeFrame: At time of CA
Secondary outcomes:
measure: Patient safety determined by contrast and radiation dose
timeFrame: At time of CA
measure: Clinical utility of dual-axis rotational coronary angiography(DARCA)
timeFrame: At time of CA
Other outcomes:
Locations:
city: Beijing
country: China
facility: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces
state: Beijing
Study officials:
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Liu Huiliang, M.D.
role: STUDY_CHAIR
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Jin Zhigeng, M.M.
role: STUDY_DIRECTOR
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Luo Jianping, M.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Yang Shengli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Ma Dongxing, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Liu Ying, M.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Han Wei, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
name: Jing Limin, B.S.M.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Maddux JT, Wink O, Messenger JC, Groves BM, Liao R, Strzelczyk J, Chen SY, Carroll JD. Randomized study of the safety and clinical utility of rotational angiography versus standard angiography in the diagnosis of coronary artery disease. Catheter Cardiovasc Interv. 2004 Jun;62(2):167-74. doi: 10.1002/ccd.20036.
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citation: Grech M, Debono J, Xuereb RG, Fenech A, Grech V. A comparison between dual axis rotational coronary angiography and conventional coronary angiography. Catheter Cardiovasc Interv. 2012 Oct 1;80(4):576-80. doi: 10.1002/ccd.23415. Epub 2012 Jan 12.
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.