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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02180971
Other study ID # DOMINATION
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date March 2021

Study information

Verified date July 2020
Source Dong-A University
Contact Moo Hyun Kim, M.D.
Phone +82-51-240-2976
Email kimmh@dau.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 2021
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
Korea, Republic of DongA University Hospital Busan

Sponsors (1)

Lead Sponsor Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Ghersin E, Litmanovich D, Dragu R, Rispler S, Lessick J, Ofer A, Brook OR, Gruberg L, Beyar R, Engel A. 16-MDCT coronary angiography versus invasive coronary angiography in acute chest pain syndrome: a blinded prospective study. AJR Am J Roentgenol. 2006 — View Citation

JCS Joint Working Group. Guidelines for diagnosis and treatment of patients with vasospastic angina (Coronary Spastic Angina) (JCS 2013). Circ J. 2014;78(11):2779-801. Epub 2014 Sep 30. — View Citation

Kang KM, Choi SI, Chun EJ, Kim JA, Youn TJ, Choi DJ. Coronary vasospastic angina: assessment by multidetector CT coronary angiography. Korean J Radiol. 2012 Jan-Feb;13(1):27-33. doi: 10.3348/kjr.2012.13.1.27. Epub 2011 Dec 23. — View Citation

Morikawa Y, Uemura S, Ishigami K, Soeda T, Okayama S, Takemoto Y, Onoue K, Somekawa S, Nishida T, Takeda Y, Kawata H, Horii M, Saito Y. Morphological features of coronary arteries in patients with coronary spastic angina: assessment with intracoronary opt — View Citation

Tsujita K, Sakamoto K, Kojima S, Kojima S, Takaoka N, Nagayoshi Y, Sakamoto T, Tayama S, Kaikita K, Hokimoto S, Sumida H, Sugiyama S, Nakamura S, Ogawa H. Coronary plaque component in patients with vasospastic angina: a virtual histology intravascular ult — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Characteristics of coronary lesion 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.
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.
Significant stenosis is defined as stenosis in more than 50% of the coronary artery diameter.
CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.
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