An observational study in Coronary Artery Disease, sponsored by General Hospital of Chinese Armed Police Forces. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by General Hospital of Chinese Armed Police Forces · Observational
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).
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.
5,677 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 576 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →General Hospital of Chinese Armed Police Forces is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Patients undergoing diagnostic coronary angiography at the General Hospital of Chinese People's Armed Police Forces.
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Exclusion Criteria:
Patients using SA for the diagnosis of coronary artery disease are assigned to the SA group.
Procedure: Standard Coronary Angiography
Patients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group.
Procedure: Dual-axis Rotational Coronary Angiography
Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.
Also known as: Conventional Coronary Angiography
Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.
Also known as: DARA, XPERSWING
Clinical safety of the patient during coronary angiography(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.
Time frame: At time of CA
Patient safety determined by contrast and radiation dose
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.
Time frame: At time of CA
Clinical utility of dual-axis rotational coronary angiography(DARCA)
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.
Time frame: At time of CA
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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General Hospital of Chinese Armed Police Forces