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

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ClinicalTrials.gov Identifier: NCT03570671
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University

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.


Condition or disease Intervention/treatment Phase
Spasm Diagnostic Test: Spasm positive Diagnostic Test: Spasm negative Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spasm positive
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).
Diagnostic Test: Spasm positive

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.

Placebo Comparator: Spasm negative
Suspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality.
Diagnostic Test: Spasm negative
Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Coronary vessel distensibility [ Time Frame: 3 days ]
    To evaluate the extent of coronary vessel distensibility by dual-acquisition of cardiac MDCTA in patients with VSA

  2. Cutoff value of coronary vessel distensibility index [ Time Frame: 3 days ]

    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:

    1. CVDI-CSA (cross-section area)= [(CSA_IV nitrate - CSA_initial) / CSA_IV nitrate]ⅹ100% or
    2. CVDI-D (diameter)= [(D_IV nitrate - D_initial) / D_IV nitrate]ⅹ100%.

  3. Incidence of multi-vessel spasm [ Time Frame: 3 days ]
    To examine the incidence of multi-vessel coronary spasm by MDCTA.

  4. Diagnostic accuracy of MDCTA [ Time Frame: 3 days ]
    To determine the diagnostic accuracy of MDCTA modalities for detection of VSA.

  5. Characteristics of spasm-related coronary artery segment [ Time Frame: 3 days ]
    To describe the characteristics of spasm-related coronary artery segment including vessel remodeling, plaque composition and stenosis degree.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570671


Contacts
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Contact: Moo Hyun Kim, MD +82-51-240-2976 kimmh@dau.ac.kr
Contact: Cai De Jin, MD +86-178-0250-2582 jincaide1118@163.com

Locations
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Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Moo Hyun Kim, MD    +82-51-240-2976    kimmh@dau.ac.kr   
Sponsors and Collaborators
Dong-A University
Investigators
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Principal Investigator: Moo Hyun Kim, MD Dong-A University Hospital

Publications:
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Responsible Party: Moo Hyun Kim, Professor, Dept. of Cardiology, Dong-A University Hospital, Dong-A University
ClinicalTrials.gov Identifier: NCT03570671     History of Changes
Other Study ID Numbers: NAVIGATOR
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Moo Hyun Kim, Dong-A University:
MDCTA
Coronary artery spasm
Additional relevant MeSH terms:
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Angina Pectoris, Variant
Neurologic Manifestations
Signs and Symptoms
Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain