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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01625533
First received: June 13, 2012
Last updated: July 4, 2013
Last verified: July 2013

June 13, 2012
July 4, 2013
June 2012
July 2013   (final data collection date for primary outcome measure)
Clinical safety of the patient during coronary angiography(CA) [ Time Frame: At time of CA ] [ Designated as safety issue: Yes ]
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 instability, chest pain lasting more than one minute and any untoward event which jeopardises the patient's life or prolongs the planned hospital stay. Hemodynamic instability is defined as severe hypotension (SBP<90 mmHg) or severe bradycardia (HR<60 beats/minute).
Same as current
Complete list of historical versions of study NCT01625533 on ClinicalTrials.gov Archive Site
  • Patient safety determined by contrast and radiation dose [ Time Frame: At time of CA ] [ Designated as safety issue: Yes ]
    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.
  • Clinical utility of dual-axis rotational coronary angiography(DARCA) [ Time Frame: At time of CA ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Dual-axis Rotational Versus Standard Coronary Angiography
Randomized Study on the Safety and Efficacy of Dual-axis Rotational Versus Standard Coronary Angiography

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients undergoing diagnostic coronary angiography at the General Hospital of Chinese People's Armed Police Forces.

Coronary Artery Disease
  • Procedure: Standard Coronary Angiography
    Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.
    Other Name: Conventional Coronary Angiography
  • Procedure: Dual-axis Rotational Coronary Angiography
    Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.
    Other Names:
    • DARA
    • XPERSWING
  • SA group
    Patients using SA for the diagnosis of coronary artery disease are assigned to the SA group.
    Intervention: Procedure: Standard Coronary Angiography
  • DARCA group
    Patients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group.
    Intervention: Procedure: Dual-axis Rotational Coronary Angiography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
576
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01625533
20120601
Yes
General Hospital of Chinese Armed Police Forces
General Hospital of Chinese Armed Police Forces
Not Provided
Study Chair: Liu Huiliang, M.D. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
Study Director: Jin Zhigeng, M.M. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
Principal Investigator: Luo Jianping, M.M. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
Principal Investigator: Yang Shengli, M.D. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
Principal Investigator: Ma Dongxing, M.D. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
Principal Investigator: Liu Ying, M.M. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
Principal Investigator: Han Wei, M.D. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
Principal Investigator: Jing Limin, B.S.M. Division of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing 100039, China
General Hospital of Chinese Armed Police Forces
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP