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Completed

NCT Number: NCT01625533

Safety and Efficacy Study 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, General Hospital of Chinese People's Armed Police Forces

Beijing, Beijing Municipality, 100039, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard Coronary Angiography

Procedure

Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.

Other names: Conventional Coronary Angiography

Dual-axis Rotational Coronary Angiography

Procedure

Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.

Other names: DARA, XPERSWING

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

General Hospital of Chinese Armed Police Forces

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2012
Registry last updated
Jun 8, 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.

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