CClinicalTrials.gg
Status unknownNCT02180971Updated Jul 22, 2020

Multidetector Coronary CT In Vasospastic Angina

An interventional study of Positive CAG with EG test and Negative CAG with EG test in Vasospastic Angina, sponsored by Dong-A University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Dong-A University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vasospastic Angina

Keywords

  • Multi-detector computed tomography angiography
  • Coronary vessel distensibility
  • Coronary spasm
03

In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

This study's planned enrollment of 150 is above the median of 123 across 336 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

Dong-A University is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    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).

    Procedure: Positive CAG with EG test

  • Experimental
    Negative CAG with EG test

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

    Procedure: Negative CAG with EG test

Interventions

  • ProcedurePositive 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).

  • ProcedureNegative CAG with EG test

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

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What researchers measure

Primary outcomes

  1. Characteristics of coronary lesion

    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.

    Time frame: CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.

07

Study locations

1 of 1 sites recruiting
  • DongA University Hospital
    Busan, 602-715, Korea, Republic of
    Recruiting
08

References and documents

Publications

  • 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. PubMed 22247633 ↗
  • 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 Jan;186(1):177-84. doi: 10.2214/AJR.04.1232. PubMed 16357399 ↗
  • 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. doi: 10.1253/circj.cj-66-0098. Epub 2014 Sep 30. No abstract available. PubMed 25273915 ↗
  • 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 ultrasound study. Int J Cardiol. 2013 Oct 3;168(3):2411-5. doi: 10.1016/j.ijcard.2013.02.002. Epub 2013 Feb 27. PubMed 23453453 ↗
  • 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 optical coherence tomography. Int J Cardiol. 2011 Feb 3;146(3):334-40. doi: 10.1016/j.ijcard.2009.07.011. Epub 2009 Aug 27. PubMed 19716193 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02180971
Lead sponsor
Dong-A University
Responsible party
Moo Hyun Kim (M.D. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital, Dong-A University) — Principal investigator
First posted
Jul 3, 2014
Start date
Apr 2014
Primary completion
Dec 2020 (estimated)
Completion
Mar 2021 (estimated)
Last update
Jul 22, 2020

Study contacts

Moo Hyun Kim, M.D.
Contact
kimmh@dau.ac.kr
+82-51-240-2976
Moo Hyun Kim, M.D.
principal investigator · Dong-A University Hospital, Busan, Republic of Korea

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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