Clinical trial NCT03570671: Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)
Official title: Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spasm
Keywords: MDCTA
Coronary artery spasm
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 3 days
Secondary outcomes:
measure: Coronary vessel distensibility
timeFrame: 3 days
measure: Cutoff value of coronary vessel distensibility index
timeFrame: 3 days
measure: Incidence of multi-vessel spasm
timeFrame: 3 days
measure: Diagnostic accuracy of MDCTA
timeFrame: 3 days
measure: Characteristics of spasm-related coronary artery segment
timeFrame: 3 days
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
Study officials:
affiliation: Dong-A University Hospital
name: Moo Hyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jin 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.