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Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR) (NAVIGATOR)

Primary Purpose

Spasm

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Spasm positive
Spasm negative
Sponsored by
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spasm focused on measuring MDCTA, Coronary artery spasm

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dong-A University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spasm positive

Spasm negative

Arm Description

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).

Suspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Coronary vessel distensibility
To evaluate the extent of coronary vessel distensibility by dual-acquisition of cardiac MDCTA in patients with VSA
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%.
Incidence of multi-vessel spasm
To examine the incidence of multi-vessel coronary spasm by MDCTA.
Diagnostic accuracy of MDCTA
To determine the diagnostic accuracy of MDCTA modalities for detection of VSA.
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.

Full Information

First Posted
May 29, 2018
Last Updated
August 3, 2020
Sponsor
Dong-A University
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1. Study Identification

Unique Protocol Identification Number
NCT03570671
Brief Title
Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)
Acronym
NAVIGATOR
Official Title
Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasm
Keywords
MDCTA, Coronary artery spasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spasm positive
Arm Type
Experimental
Arm Description
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).
Arm Title
Spasm negative
Arm Type
Placebo Comparator
Arm Description
Suspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality.
Intervention Type
Diagnostic Test
Intervention Name(s)
Spasm positive
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Spasm negative
Intervention Description
Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Coronary vessel distensibility
Description
To evaluate the extent of coronary vessel distensibility by dual-acquisition of cardiac MDCTA in patients with VSA
Time Frame
3 days
Title
Cutoff value of coronary vessel distensibility index
Description
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%.
Time Frame
3 days
Title
Incidence of multi-vessel spasm
Description
To examine the incidence of multi-vessel coronary spasm by MDCTA.
Time Frame
3 days
Title
Diagnostic accuracy of MDCTA
Description
To determine the diagnostic accuracy of MDCTA modalities for detection of VSA.
Time Frame
3 days
Title
Characteristics of spasm-related coronary artery segment
Description
To describe the characteristics of spasm-related coronary artery segment including vessel remodeling, plaque composition and stenosis degree.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moo Hyun Kim, MD
Phone
+82-51-240-2976
Email
kimmh@dau.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Cai De Jin, MD
Phone
+86-178-0250-2582
Email
jincaide1118@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moo Hyun Kim, MD
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo Hyun Kim, MD
Phone
+82-51-240-2976
Email
kimmh@dau.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27380904
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.
Results Reference
background
PubMed Identifier
29166637
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.
Results Reference
background

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Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)

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