Multidetector Coronary CT In Vasospastic Angina

Not Applicable

• Conditions: Vasospastic Angina
• Interventions: Procedure: Negative CAG with EG test; Procedure: Positive CAG with EG test

• Registration Number: NCT02180971
• Lead Sponsor: Dong-A University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-29
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative CAG with EG test	Negative CAG with EG test	Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection
Positive CAG with EG test	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).

Primary Outcome Measures

Name	Time	Method
Characteristics of coronary lesion	CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.	1. Plaque composition: noncalcified plaque, which is \< 130 Hounsfield units(HU). Calcified plaque with a density of \> 130 HU. Mixed plaque: plaque area consisted of \> 50% of non-calcified plaque.; 2. The remodeling index (RI) was calculated by dividing the cross-sectional lesion vessel-area by the reference vessel area.Positive remodeling was defined as RI \> 1.05, otherwise RI ≤0.95.; 3. Significant stenosis is defined as stenosis in more than 50% of the coronary artery diameter.

Trial Locations

Locations (1)

DongA University Hospital; 🇰🇷 Busan, Korea, Republic of