Multidetector Coronary CT In Vasospastic Angina

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2021-03-31

Brief Summary

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The purpose of this study is to compare the extent of coronary vessel stenosis between coronary spasm-induced angina attacks (named vasospastic angina, VSA) patients and health volunteers by multi-detector computed tomography angiography (MDCTA), and to evaluate the diagnostic efficacy of MDCTA in patients with VSA.

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Detailed Description

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Vasospastic angina (VSA) was characterized by transient ischemic ST-segment change during angina attacks. Coronary spasm provocation test, as a diagnostic golden standard, has been widely used for the management of VSA according to JCS 2013 guidelines.

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 including multi-detector computed tomography angiography (MDCTA) with high diagnostic accuracy to evaluate coronary artery stenosis. However, the diagnostic accuracy of MDCTA in patients with VSA is lacking.

Therefore, more efficient and safe noninvasive diagnostic method is required for the detection of angina-like attacks patients.

Conditions

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Vasospastic Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Positive CAG with EG test

A positive finding for coronary angiography with an ergonovine provocation test is defined as transient, total, or sub-total occlusion (\>90% stenosis) with signs/symptoms of myocardial ischemia (chest pain and ischemic ECG change).

Group Type EXPERIMENTAL

Positive CAG with EG test

Intervention Type PROCEDURE

A positive finding for coronary angiography with an ergonovine provocation test is defined as transient, total, or sub-total occlusion (\>90% stenosis) with signs/symptoms of myocardial ischemia (chest pain and ischemic ECG change).

Negative CAG with EG test

Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection

Group Type EXPERIMENTAL

Negative CAG with EG test

Intervention Type PROCEDURE

Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection

Interventions

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Positive CAG with EG test

A positive finding for coronary angiography with an ergonovine provocation test is defined as transient, total, or sub-total occlusion (\>90% stenosis) with signs/symptoms of myocardial ischemia (chest pain and ischemic ECG change).

Intervention Type PROCEDURE

Negative CAG with EG test

Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Onset of angina-like attack at rest, during effort, or during rest and effort.
* Patients will be scheduled to undergo multi-detector computed tomography angiography and coronary angiography with an ergonovine provocation test.

Exclusion Criteria

* Evidence of acute coronary syndrome, cardiomyopathy and valvular heart disease.
* More than 50% stenosis detected by coronary angiography .
* Renal insufficiency (serum creatine\>2.5 mg/dl).

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes