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

General Hospital of Chinese Armed Police Forces

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Standard Coronary Angiography; Procedure: Dual-axis Rotational Coronary Angiography

Study type: Observational

Funder types: Other

Identifiers

NCT01625533

20120601

Details and patient eligibility

About

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).

Full 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.

Enrollment: 576 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

576 participants in 2 patient groups

SA group

Description:

Patients using SA for the diagnosis of coronary artery disease are assigned to the SA group.

Treatment:

Procedure: Standard Coronary Angiography

DARCA group

Description:

Patients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group.

Treatment:

Procedure: Dual-axis Rotational Coronary Angiography