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Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)

NCT03570671 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-08-04

No results posted yet for this study

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.

Conditions

  • Spasm

Interventions

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.

Sponsors & Collaborators

  • Dong-A University

    lead OTHER

Principal Investigators

  • Moo Hyun Kim, MD · Dong-A University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-05-31
Completion
2021-07-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570671 on ClinicalTrials.gov