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

August 3, 2020 updated by: Moo Hyun Kim, Dong-A University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Recruiting
        • Dong-A University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days
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 days
Incidence of multi-vessel spasm
Time Frame: 3 days
To examine the incidence of multi-vessel coronary spasm by MDCTA.
3 days
Diagnostic accuracy of MDCTA
Time Frame: 3 days
To determine the diagnostic accuracy of MDCTA modalities for detection of VSA.
3 days
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

June 16, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Navigator

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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