Skip to main content
OpenTrials
Completed

NCT Number: NCT01776866

Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General hospital of Chinese people's armed police forces

Beijing, 100039, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Angiography

Procedure

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.

Primary outcomes

  1. Diagnosis of Coronary Heart Disease

    Time frame: After coronary angiography, an expected average of 1 month

    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%.

Secondary outcomes

  1. Coronary Lesion Assessment

    Time frame: After coronary angiography, an expected average of 1 month

    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 greater than or equal to 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)

  2. Quantitative Coronary Angiography

    Time frame: After coronary angiography, an expected average of 1 month

    The quantitative coronary angiography analysis of the more than or equal to 50% lesions detected by the lesion assessment of either reviewer one or reviewer two in both angiographic modalities (lesion length, minimum lumen diameter, diameter stenosis). Quantitative coronary angiography analysis will be performed by the third different blinded, independent, reviewer.

  3. Diagnostic Screening Adequacy

    Time frame: After coronary angiography, an expected average of 1 month

    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.

Other outcomes

  1. Safety Analysis

    Time frame: During coronary angiography

    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.

Sponsors and collaborators

Lead sponsor

General Hospital of Chinese Armed Police Forces

Other

Registry information

Official study title

Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2013
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.