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Clinical Trials/NCT02180971
NCT02180971
Unknown
Not Applicable

Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina

Dong-A University1 site in 1 country150 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vasospastic Angina
Sponsor
Dong-A University
Enrollment
150
Locations
1
Primary Endpoint
Characteristics of coronary lesion
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
March 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moo Hyun Kim

M.D. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital

Dong-A University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Characteristics of coronary lesion

Time Frame: 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.

Study Sites (1)

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