Multidetector Coronary CT In Vasospastic Angina

Vasospastic Angina Clinical Trial

Official title:

Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02180971
• Other study ID #: DOMINATION
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Vasospastic Angina

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.