Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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

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Spasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spasm positive

Ergonovine-induced coronary spasm provocation test positive: defined as transient, total, or sub-total occlusion (\>90% stenosis) of a coronary artery with symptoms of myocardial ischemia (angina pain and ischemic ECG change).

Group Type EXPERIMENTAL

Spasm positive

Intervention Type DIAGNOSTIC_TEST

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.

Spasm negative

Suspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality.

Group Type PLACEBO_COMPARATOR

Spasm negative

Intervention Type DIAGNOSTIC_TEST

Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Spasm negative

Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subject is onset of angina-like attack at rest, during effort, or during rest and effort.
* Subject has chest pain between night and early morning.
* Subject is scheduled to undergo MDCTA.
* Subject is an acceptable candidate for CAG with an EG provocation test.
* Cardiac condition: BP\>90/60mmHg, ECG: sinus rhythm with regular, left ventricular ejection fraction\>55%, and resting heart rate\<100 beats/min.
* Subject will be provided written informed consent.
* Subject is willing to comply with study follow-up requirement.

Exclusion Criteria

* Subject has clinical evidence of acute coronary syndrome.
* Subject has evidence of significant narrowing (\>50% stenosis by CAG).
* Subject has clinical evidence of cardiomyopathy or valvular heart disease.
* Subject is hemodynamically unstable.
* Subject has a history of PCI and CABG.
* Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
* Subject has known allergy to contrast medium.
* Subject has renal insufficiency (serum creatine \>2.5 mg/dl).

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No