Vasospastic AnginaNCT02180971
Multidetector Coronary CT In Vasospastic Angina
A study testing Positive CAG with EG test and Negative CAG with EG test in people with Vasospastic Angina, run by Dong-A University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasospastic Angina
- What is being tested?
- Positive CAG with EG test and Negative CAG with EG test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
DongA University Hospital
Busan, 602-715
Moo Hyun Kim, M.D., +82-51-240-2976, kimmh@dau.ac.kr
About this study
Official title: Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina
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.
- Conditions
- Vasospastic Angina
- Being tested
- Positive CAG with EG test, Negative CAG with EG test
- Keywords
- Multi-detector computed tomography angiography, Coronary vessel distensibility, Coronary spasm
- Medical subject headings
- Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive CAG with EG testProcedure or surgery
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 testProcedure or surgery
Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection
| Study group | Role | What they receive |
|---|---|---|
| Positive CAG with EG test | Experimental | 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). Receives: Procedure: Positive CAG with EG test |
| Negative CAG with EG test | Experimental | Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection Receives: Procedure: Negative CAG with EG test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vasospastic AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moo Hyun Kim, Dong-A University
- Investigators
- Moo Hyun Kim, M.D., Principal investigator, Dong-A University Hospital, Busan, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180971
- Sponsor's protocol ID
- DOMINATION
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2014
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 22247633Ghersin 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 16357399JCS 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 25273915Tsujita 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 23453453Morikawa 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina
- ClinicalTrials.gov ID
- NCT02180971
- Acronym / sponsor ID
- DOMINATION
- Conditions
- Vasospastic Angina
- Keywords
- Multi-detector computed tomography angiography, Coronary vessel distensibility, Coronary spasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive CAG with EG test | Experimental | Procedure: Positive CAG with EG testA 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 | Experimental | Procedure: Negative CAG with EG testNegative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive CAG with EG testA 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 or surgery | Positive CAG with EG test |
| Negative CAG with EG testNegative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection | Procedure or surgery | Negative CAG with EG test |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Results publication: PubMed 22247633Kang 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.
- Results publication: PubMed 16357399Ghersin 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.
- Results publication: PubMed 25273915JCS 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.
- Results publication: PubMed 23453453Tsujita 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.
- Results publication: PubMed 19716193Morikawa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo Hyun Kim, M.D. principal investigator
Dong-A University Hospital, Busan, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive CAG with EG test and Negative CAG with EG test in people with Vasospastic Angina, run by Dong-A University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moo Hyun Kim, M.D. (+82-51-240-2976, kimmh@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of coronary lesion (time frame: CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180971, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.