SpasmNAVIGATORNCT03570671
Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)
A study testing Spasm positive and Spasm negative in people with Spasm, run by Dong-A University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spasm
- What is being tested?
- Spasm positive and Spasm negative
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2018to 1 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is onset of angina-like attack at rest, during effort, or during rest and effort.
- Subject has chest pain between night and early morning.
- Subject is scheduled to undergo MDCTA.
- Subject is an acceptable candidate for CAG with an EG provocation test.
- Cardiac condition: BP>90/60mmHg, ECG: sinus rhythm with regular, left ventricular ejection fraction>55%, and resting heart rate<100 beats/min.
- Subject will be provided written informed consent.
- Subject is willing to comply with study follow-up requirement.
Who cannot join
- Subject has clinical evidence of acute coronary syndrome.
- Subject has evidence of significant narrowing (>50% stenosis by CAG).
- Subject has clinical evidence of cardiomyopathy or valvular heart disease.
- Subject is hemodynamically unstable.
- Subject has a history of PCI and CABG.
- Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
- Subject has known allergy to contrast medium.
- Subject has renal insufficiency (serum creatine >2.5 mg/dl).
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dong-A University Hospital
Busan, 602-715
Moo Hyun Kim, MD, +82-51-240-2976, kimmh@dau.ac.kr
About this study
Official title: Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
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 in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.
Read the detailed description
Previously investigators analyzed the characteristics of coronary spasm segment in an observational individual dataset, suspected VSA patients (n=20) underwent dual-acquisition of MDCTA (initial and intravenous nitrate injected CT imaging), the diagnostic accuracy showed sensitivity: 73%, specificity: 100%, positive predictive value: 100%, and negative predictive value: 56%.
Further study is necessary because previous analysis presented limited sample size and deficiency of healthy control.
Therefore, investigators hypothesis that dual-acquisition of MDCTA in noninvasive tool for coronary assessment provide more information of coronary characteristics, and the diagnostic efficacy would be non-inferior as compared with the invasive coronary imaging modality in coronary spasm-induced angina attacks.
- Conditions
- Spasm
- Being tested
- Spasm positive, Spasm negative
- Keywords
- MDCTA, Coronary artery spasm
- Medical subject headings
- Spasm, Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spasm positiveDiagnostic test
Investigators define the positive criteria for VSA on MDCTA as follows:
- Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or
- Diffuse small diameter (< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT.
Spasm negativeDiagnostic test
Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.
| Study group | Role | What they receive |
|---|---|---|
| Spasm positive | Experimental | Ergonovine-induced coronary spasm provocation test positive: defined as transient, total, or sub-total occlusion (>90% stenosis) of a coronary artery with symptoms of myocardial ischemia (angina pain and ischemic ECG change). Receives: Diagnostic Test: Spasm positive |
| Spasm negative | Placebo comparator | Suspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality. Receives: Diagnostic Test: Spasm negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
MDCTA procedure: all subjects will undergo MDCTA without a vasodilator ("initial CT") in the early morning before the ergonovine provocation spasm test. Subsequent "IV nitrate CT" will be allowed at a 3-day washout period after the first contrast usage. The scan protocol for the IV nitrate CT is as follows: during continuous injection of the intravenous vasodilating agent (isosorbidedinitrate 2 mg/hr), blood pressure will be checked every 2 minutes. When both the systolic and diastolic blood pressure decrease by 10 mmHg in comparison to the initial value, the CT scan initiate and images will be acquired during the nitrate infusion.
Investigators define the positive criteria for VSA on MDCTA as follows:
- Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or
- Diffuse small diameter (< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT.
Measured: 3 days
Secondary outcomes (5)
Coronary vessel distensibility
To evaluate the extent of coronary vessel distensibility by dual-acquisition of cardiac MDCTA in patients with VSA
Measured: 3 days
Cutoff value of coronary vessel distensibility index
To consider the cutoff value of coronary vessel distensibility index (CVDI) to predict the coronary spasm induced angina-like attacks.
Investigators define the CVDI as following formulas:
- CVDI-CSA (cross-section area)= [(CSA_IV nitrate - CSA_initial) / CSA_IV nitrate]ⅹ100% or
- CVDI-D (diameter)= [(D_IV nitrate - D_initial) / D_IV nitrate]ⅹ100%.
Measured: 3 days
Incidence of multi-vessel spasm
To examine the incidence of multi-vessel coronary spasm by MDCTA.
Measured: 3 days
Diagnostic accuracy of MDCTA
To determine the diagnostic accuracy of MDCTA modalities for detection of VSA.
Measured: 3 days
Characteristics of spasm-related coronary artery segment
To describe the characteristics of spasm-related coronary artery segment including vessel remodeling, plaque composition and stenosis degree.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Mar 2018
- Primary completion31 May 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SpasmStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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, MD, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570671
- Sponsor's protocol ID
- NAVIGATOR
- Acronym
- NAVIGATOR
- Status last verified
- Aug 2020
- First submitted
- 29 May 2018
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang EJ, Kim MH, De Jin C, Seo J, Kim DW, Yoon SK, Park TH, Lee KN, Choi SI, Yoon YE. Noninvasive detection of coronary vasospastic angina using a double-acquisition coronary CT angiography protocol in the presence and absence of an intravenous nitrate: a pilot study. Eur Radiol. 2017 Mar;27(3):1136-1147. doi: 10.1007/s00330-016-4476-2. Epub 2016 Jul 6.
PubMed 27380904Jin C, Kim MH, Kang EJ, Cho YR, Park TH, Lee KN, Serebruany V. Assessing Vessel Tone during Coronary Artery Spasm by Dual-Acquisition Multidetector Computed Tomography Angiography. Cardiology. 2018;139(1):25-32. doi: 10.1159/000478926. Epub 2017 Nov 23.
PubMed 29166637
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
- ClinicalTrials.gov ID
- NCT03570671
- Acronym / sponsor ID
- NAVIGATOR / NAVIGATOR
- Conditions
- Spasm
- Keywords
- MDCTA, Coronary artery spasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 27 Jun 2018 (actual)
- 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.
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 in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.
Detailed description
Previously investigators analyzed the characteristics of coronary spasm segment in an observational individual dataset, suspected VSA patients (n=20) underwent dual-acquisition of MDCTA (initial and intravenous nitrate injected CT imaging), the diagnostic accuracy showed sensitivity: 73%, specificity: 100%, positive predictive value: 100%, and negative predictive value: 56%.
Further study is necessary because previous analysis presented limited sample size and deficiency of healthy control.
Therefore, investigators hypothesis that dual-acquisition of MDCTA in noninvasive tool for coronary assessment provide more information of coronary characteristics, and the diagnostic efficacy would be non-inferior as compared with the invasive coronary imaging modality in coronary spasm-induced angina attacks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spasm positive | Experimental | Diagnostic Test: Spasm positiveErgonovine-induced coronary spasm provocation test positive: defined as transient, total, or sub-total occlusion (>90% stenosis) of a coronary artery with symptoms of myocardial ischemia (angina pain and ischemic ECG change). |
| Spasm negative | Placebo comparator | Diagnostic Test: Spasm negativeSuspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is onset of angina-like attack at rest, during effort, or during rest and effort.
- Subject has chest pain between night and early morning.
- Subject is scheduled to undergo MDCTA.
- Subject is an acceptable candidate for CAG with an EG provocation test.
- Cardiac condition: BP>90/60mmHg, ECG: sinus rhythm with regular, left ventricular ejection fraction>55%, and resting heart rate<100 beats/min.
Key exclusion criteria (8 listed)
- Subject has clinical evidence of acute coronary syndrome.
- Subject has evidence of significant narrowing (>50% stenosis by CAG).
- Subject has clinical evidence of cardiomyopathy or valvular heart disease.
- Subject is hemodynamically unstable.
- Subject has a history of PCI and CABG.
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 |
|---|---|---|
| Spasm positiveInvestigators define the positive criteria for VSA on MDCTA as follows: 1. Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or 2. Diffuse small diameter (< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT. | Diagnostic test | Spasm positive |
| Spasm negativeSuspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality. | Diagnostic test | Spasm negative |
Primary outcome
Safety and Tolerability
Time frame: 3 days
MDCTA procedure: all subjects will undergo MDCTA without a vasodilator ("initial CT") in the early morning before the ergonovine provocation spasm test. Subsequent "IV nitrate CT" will be allowed at a 3-day washout period after the first contrast usage. The scan protocol for the IV nitrate CT is as follows: during continuous injection of the intravenous vasodilating agent (isosorbidedinitrate 2 mg/hr), blood pressure will be checked every 2 minutes. When both the systolic and diastolic blood pressure decrease by 10 mmHg in comparison to the initial value, the CT scan initiate and images will be acquired during the nitrate infusion. Investigators define the positive criteria for VSA on MDCTA as follows: 1. Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or 2. Diffuse small diameter (< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT.
5 secondary outcomes
Coronary vessel distensibility
Time frame: 3 days
Cutoff value of coronary vessel distensibility index
Time frame: 3 days
Incidence of multi-vessel spasm
Time frame: 3 days
Diagnostic accuracy of MDCTA
Time frame: 3 days
Characteristics of spasm-related coronary artery segment
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Background: PubMed 27380904Kang EJ, Kim MH, De Jin C, Seo J, Kim DW, Yoon SK, Park TH, Lee KN, Choi SI, Yoon YE. Noninvasive detection of coronary vasospastic angina using a double-acquisition coronary CT angiography protocol in the presence and absence of an intravenous nitrate: a pilot study. Eur Radiol. 2017 Mar;27(3):1136-1147. doi: 10.1007/s00330-016-4476-2. Epub 2016 Jul 6.
- Background: PubMed 29166637Jin C, Kim MH, Kang EJ, Cho YR, Park TH, Lee KN, Serebruany V. Assessing Vessel Tone during Coronary Artery Spasm by Dual-Acquisition Multidetector Computed Tomography Angiography. Cardiology. 2018;139(1):25-32. doi: 10.1159/000478926. Epub 2017 Nov 23.
- Individual participant dataSharing planned: Undecided
Related trials for Spasm
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruiting
Autologous PRP Versus Triamcinolone Acetate in Patients With Oral Submucous Fibrosis
Oral Submucous Fibrosis
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
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, MD principal investigator
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spasm positive and Spasm negative in people with Spasm, 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 7 inclusion and 8 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 4 Aug 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. Some participants in this study may receive a placebo. 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, MD (+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?
Safety and Tolerability (time frame: 3 days). 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 NCT03570671, which also lists 2 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 4 Aug 2020.