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

June 3, 2015 updated by: General Hospital of Chinese Armed Police Forces

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

576

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Division of Cardiology, General Hospital of Chinese People's Armed Police Forces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical safety of the patient during coronary angiography(CA)
Time Frame: At time of 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient safety determined by contrast and radiation dose
Time Frame: At time of CA
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
Clinical utility of dual-axis rotational coronary angiography(DARCA)
Time Frame: At time of CA
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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