Multidetector Coronary CT In Vasospastic Angina

Dong-A University

Status: Unknown

Conditions: Vasospastic Angina

Treatments: Procedure: Positive CAG with EG test; Procedure: Negative CAG with EG test

Study type: Interventional

Funder types: Other

Identifiers

NCT02180971

DOMINATION

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Positive CAG with EG test

Experimental group

Description:

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).

Treatment:

Procedure: Positive CAG with EG test

Negative CAG with EG test

Experimental group

Description:

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

Treatment:

Procedure: Negative CAG with EG test