Safety and Efficacy Study of Dual-axis Rotational Versus Standard Coronary Angiography

Coronary Artery Disease Clinical Trial

Official title:

Randomized Study on the Safety and Efficacy of Dual-axis Rotational Versus Standard Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625533
• Other study ID #: 20120601
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: June 3, 2015
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: General Hospital of Chinese Armed Police Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Standard Coronary Angiography
Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.
• Dual-axis Rotational Coronary Angiography
Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.

Locations

Country	Name	City	State
China	Division of Cardiology, General Hospital of Chinese People's Armed Police Forces	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

References & Publications (7)

Empen K, Kuon E, Hummel A, Gebauer C, Dörr M, Könemann R, Hoffmann W, Staudt A, Weitmann K, Reffelmann T, Felix SB. Comparison of rotational with conventional coronary angiography. Am Heart J. 2010 Sep;160(3):552-63. doi: 10.1016/j.ahj.2010.06.011. — View 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. — View Citation

Gómez-Menchero AE, Díaz JF, Sánchez-González C, Cardenal R, Sanghvi AB, Roa-Garrido J, Rodríguez-López JL. Comparison of dual-axis rotational coronary angiography (XPERSWING) versus conventional technique in routine practice. Rev Esp Cardiol (Engl Ed). 2012 May;65(5):434-9. doi: 10.1016/j.recesp.2011.12.014. Epub 2012 Apr 1. English, Spanish. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical safety of the patient during coronary angiography(CA)	The patients were closely observed and questioned regarding discomfort and adverse events during or immediately after CA. The sensation of warmth or pain, including chest pain, is considered as discomfort. Adverse events include arrhythmias, hemodynamic compromise, chest pain described as angina-like pain and any untoward event which jeopardises the patient's life or prolongs the planned hospital stay. If patients experienced bradycardia, only bradycardia with a decrease in heart rate of 20% from the baseline was counted. Hemodynamic compromise was defined as a decrease in systolic blood pressure by > 20 mmHg to < 90 mmHg.	At time of CA	Yes
Secondary	Patient safety determined by contrast and radiation dose	The contrast usage (ml) and radiation exposure (mGycm2) are recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The contrast and radiation to perform isocentering are included during DARCA. The contrast and radiation required to engage the coronary ostia, exchange catheters, and perform non-coronary angiography are excluded from the analysis.	At time of CA	Yes
Secondary	Clinical utility of dual-axis rotational coronary angiography(DARCA)	The clinical utility of DARCA is determined by the number of additional acquisitions required beyond the protocol and the procedure time required for completing CA.The procedure time (sec.) is recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The time to perform isocentering is included during DARCA. The time required to engage the coronary ostia, exchange catheters, and perform non-coronary angiography is excluded from the analysis.	At time of CA	No