Multidetector Coronary CT In Vasospastic Angina
Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJuly 22, 2020
July 1, 2020
6.7 years
June 29, 2014
July 21, 2020
Conditions
Keywords
Outcome Measures
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.
CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.
Study Arms (2)
Positive CAG with EG test
EXPERIMENTALA 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
EXPERIMENTALNegative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection
Interventions
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 test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DongA University Hospital
Busan, 602-715, South Korea
Related Publications (5)
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.
PMID: 22247633RESULTGhersin 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.
PMID: 16357399RESULTJCS 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.
PMID: 25273915RESULTTsujita 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.
PMID: 23453453RESULTMorikawa 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.
PMID: 19716193RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moo Hyun Kim, M.D.
Dong-A University Hospital, Busan, Republic of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital
Study Record Dates
First Submitted
June 29, 2014
First Posted
July 3, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2020
Study Completion
March 1, 2021
Last Updated
July 22, 2020
Record last verified: 2020-07