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
  Purpose

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).


Condition Intervention
Coronary Artery Disease
Procedure: Standard Coronary Angiography
Procedure: Dual-axis Rotational Coronary Angiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Study on the Safety and Efficacy of Dual-axis Rotational Versus Standard Coronary Angiography

Resource links provided by NLM:


Further study details as provided by General Hospital of Chinese Armed Police Forces:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 576
Study Start Date: June 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SA group
Patients using SA for the diagnosis of coronary artery disease are assigned to the SA group.
Procedure: Standard Coronary Angiography
Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.
Other Name: Conventional Coronary Angiography
DARCA group
Patients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group.
Procedure: Dual-axis Rotational Coronary Angiography
Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.
Other Names:
  • DARA
  • XPERSWING

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625533

Locations
China, Beijing
Division of Cardiology, General Hospital of Chinese People's Armed Police Forces
Beijing, Beijing, China, 100039
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
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
  More Information

Publications:

Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01625533     History of Changes
Other Study ID Numbers: 20120601
Study First Received: June 13, 2012
Last Updated: July 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by General Hospital of Chinese Armed Police Forces:
Coronary Angiography
Rotational Coronary Angiography
Contrast media
Radiation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014