Image Content Analysis of Dural-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:
NCT01776866
First received: January 16, 2013
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.


Condition Intervention
Coronary Artery Disease
Procedure: Coronary Angiography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Diagnosis of Coronary Heart Disease [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]
    The number of patients diagnosed as coronary heart disease by either angiographic modality by two blinded independent reviewers are recorded. The single criterion for diagnosis of coronary heart disease is the presence of coronary artery stenoses greater than or equal to 50%.

  • Coronary Lesion Assessment [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]
    The number of lesions greater than or equal to 50% detected by either angiographic modality by two blinded independent reviewers are recorded.In addition, they are asked to comment on the characteristics of the >50% lesions (number of coronary lesions, number of bifurcation lesions, location of lesion, multivessel disease, American College of Cardiology (ACC) lesion classification and Medina classification for bifurcation lesions)

  • Diagnostic Screening Adequacy [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]
    Two different experienced reviewers analyzed the angiographic sets based on a Likert Scale for each vessel segment, calcification, thrombolysis in myocardial infarction (TIMI) flow, collaterals, displaying the lesions and bifurcations.

  • Quantitative Coronary Angiography [ Time Frame: After the patient enrolment, an expected average of 1 week ] [ Designated as safety issue: No ]
    The quantitative coronary angiography analysis of the >50% lesions detected by the lesion assessment of both angiographic modalities (lesion length, minimum lumen diameter, diameter stenosis).


Secondary Outcome Measures:
  • Safety Analysis [ Time Frame: During coronary angiography ] [ Designated as safety issue: Yes ]
    The time(seconds), contrast usage(ml) and radiation dose(Gycm2) are recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The time, contrast and radiation to perform isocentering are included during dura-axis rotational coronary angiography. The time, contrast and radiation to engage the coronary ostium, exchange catheters, and perform non-coronary angiography are excluded from the analysis. All adverse events observed by the operator or reported by the patient are recorded.


Enrollment: 70
Study Start Date: January 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Coronary Angiography

Patient first undergo standard coronary angiography(SA) of either left or right coronary system followed by dual-axis rotational coronary angiography(DARCA). The SA protocol consist of six different projections (right anterior oblique (RAO)-caudal, RAO-cranial (CRA), left anterior oblique (LAO)-CRA, LAO-caudal (CAU), antero-posterior (AP)-CRA and AP-CAU) for left coronary artery (LCA) and two projections (LAO and AP-cranial) for right coronary artery (RCA).

The DARCA protocol consist of two coronary acquisitions specified by the protocol: one for LCA (Swing LCA CRA 35 5.8s), another for RCA (Swing RCA AP 4.0s).

Procedure: Coronary Angiography
Coronary angiography include standard coronary angiography (SA) and dual-axis rotational coronary angiography (DARCA). Patient first undergo SA of either left or right coronary system followed by DARCA.

Detailed Description:

The prior studies have demonstrated that dual-axis rotational coronary angiography (DARCA) is associated with lower contrast usage and radiation exposure compared with standard coronary angiography (SA). Single-axis rotational coronary angiography (RA) has been proved by previous studies without any reduction in diagnostic accuracy compared to SA. However, the rotational protocol is obvious different between DARCA and single-axis RA. A recent study has assessed the diagnostic accuracy of DARCA, but this study was not designed for image content analysis and the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The diagnostic accuracy of DARCA aroused our attention.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18 years old, <80 years old
  • a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease

Exclusion Criteria:

  • Pregnancy
  • Known allergy to iodinated contrast
  • Patients who had received iodinated contrast material within the last week or were unable to give consent
  • Renal insufficiency (>1.5mg/dL)
  • Acute myocardial infarction within one week
  • Cardiogenic shock
  • heart function worse than New York Heart Association functional class III
  • Left main coronary artery disease
  • 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: NCT01776866

Locations
China
General hospital of Chinese people's armed police forces
Beijing, China, 100039
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
Study Chair: Liu Huiliang, M.D. General hospital of Chinese people's armed police forces
Study Director: Jin Zhigeng, M.M. General hospital of Chinese people's armed police forces
Principal Investigator: Yang Shengli, M.D. General hospital of Chinese people's armed police forces
Principal Investigator: Luo Jianping, M.M. General hospital of Chinese people's armed police forces
Principal Investigator: Ma Dongxing, M.D. General hospital of Chinese people's armed police forces
Principal Investigator: Liu Ying, M.M. General hospital of Chinese people's armed police forces
Principal Investigator: Han Wei, M.D. General hospital of Chinese people's armed police forces
Principal Investigator: Jing Limin, B.S.M. General hospital of Chinese people's armed police forces
  More Information

Publications:
Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01776866     History of Changes
Other Study ID Numbers: 20130101, 20130101
Study First Received: January 16, 2013
Last Updated: May 14, 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
Quantitative Coronary Angiography

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 19, 2014