Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)

Spasm Clinical Trial

— NAVIGATOR  

Official title:

Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570671
• Other study ID #: NAVIGATOR
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2020
• Source: Dong-A University
• Contact: Moo Hyun Kim, MD
• Phone: +82-51-240-2976
• Email: kimmh[@]dau.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Angina Pectoris, Variant
• Spasm

Intervention

Diagnostic Test:
• Spasm positive
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 negative
Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days
Secondary	Coronary vessel distensibility	To evaluate the extent of coronary vessel distensibility by dual-acquisition of cardiac MDCTA in patients with VSA	3 days
Secondary	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]?100% or; CVDI-D (diameter)= [(D_IV nitrate - D_initial) / D_IV nitrate]?100%.	3 days
Secondary	Incidence of multi-vessel spasm	To examine the incidence of multi-vessel coronary spasm by MDCTA.	3 days
Secondary	Diagnostic accuracy of MDCTA	To determine the diagnostic accuracy of MDCTA modalities for detection of VSA.	3 days
Secondary	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.	3 days