Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)
NAVIGATOR
Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
1 other identifier
interventional
90
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
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
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedAugust 4, 2020
August 1, 2020
3.3 years
May 29, 2018
August 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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.
3 days
Secondary Outcomes (5)
Coronary vessel distensibility
3 days
Cutoff value of coronary vessel distensibility index
3 days
Incidence of multi-vessel spasm
3 days
Diagnostic accuracy of MDCTA
3 days
Characteristics of spasm-related coronary artery segment
3 days
Study Arms (2)
Spasm positive
EXPERIMENTALErgonovine-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 COMPARATORSuspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality.
Interventions
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.
Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dong-A University Hospital
Busan, 602-715, South Korea
Related Publications (2)
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.
PMID: 27380904BACKGROUNDJin 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.
PMID: 29166637BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moo Hyun Kim, MD
Dong-A University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Dept. of Cardiology, Dong-A University Hospital
Study Record Dates
First Submitted
May 29, 2018
First Posted
June 27, 2018
Study Start
March 1, 2018
Primary Completion
May 31, 2021
Study Completion
July 1, 2021
Last Updated
August 4, 2020
Record last verified: 2020-08