NCT03570671

Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)

Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Dong-A University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

With regard to the characteristics of spasm segment, had been clearly described by other invasive imaging methods including intravascular ultrasound and optical coherence tomography. However, there is potential risk during these invasive procedures, such as severe myocardial ischemia or fatal arrhythmia. Presently available imaging test for coronary artery disease in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.

Detailed description

Previously investigators analyzed the characteristics of coronary spasm segment in an observational individual dataset, suspected VSA patients (n=20) underwent dual-acquisition of MDCTA (initial and intravenous nitrate injected CT imaging), the diagnostic accuracy showed sensitivity: 73%, specificity: 100%, positive predictive value: 100%, and negative predictive value: 56%. Further study is necessary because previous analysis presented limited sample size and deficiency of healthy control. Therefore, investigators hypothesis that dual-acquisition of MDCTA in noninvasive tool for coronary assessment provide more information of coronary characteristics, and the diagnostic efficacy would be non-inferior as compared with the invasive coronary imaging modality in coronary spasm-induced angina attacks.

Conditions

• Spasm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Spasm positive	Investigators define the positive criteria for VSA on MDCTA as follows: 1. Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or 2. Diffuse small diameter (\< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT.
DIAGNOSTIC_TEST	Spasm negative	Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-05-31
• Completion: 2021-07-01
• First posted: 2018-06-27
• Last updated: 2020-08-04

Locations

1 site across 1 country: South Korea