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

Study Overview
=================
Brief Summary
-----------------
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).

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.

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Standard Coronary Angiography
* Procedure: Dual-axis Rotational Coronary Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SA group<br>Patients using SA for the diagnosis of coronary artery disease are assigned to the SA group. | Procedure: Standard Coronary Angiography<br>* Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.<br>* Other names: Conventional Coronary Angiography;|
| DARCA group<br>Patients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group. | Procedure: Dual-axis Rotational Coronary Angiography<br>* Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.<br>* Other names: XPERSWING;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At time of CA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At time of CA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Angiography, Rotational Coronary Angiography, Contrast media, Radiation