search
Back to results

Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death (VARIANT ICD)

Primary Purpose

Angina Pectoris, Variant, Sudden Cardiac Death

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator
Optimal Medical Therapy
Sponsored by
Kee-joon Choi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris, Variant focused on measuring Variant angina, Aborted sudden cardiac death, Implantable Cardioverter Defibrillator, Optimal Medical Therapy, ICD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia
  • Diagnosed as variant angina, defined by spontaneous coronary spasm with ST elevation (≥0.1mV) in the coronary angiogram and/or documented coronary spasm on ergonovine provocation coronary angiography

Exclusion Criteria:

  • Significant (>50%) coronary artery stenosis on coronary angiography

  • Organic heart disease known to be associated with sudden cardiac arrest.

    • Heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction < 35%)
    • Presence of LV akinesia or aneurysm
    • Hypertrophic cardiomyopathy
    • Arrhythmogenic right ventricular dysplasia
  • Chronic Heart Failure New York Heart Association functional class III or IV
  • prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)
  • Prior catheter ablation for ventricular arrhythmia
  • Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)
  • Prior pacemaker or Implantable Cardioverter Defibrillator
  • 2nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker
  • Patients with poor neurologic outcome (defined as cerebral performance category scale ≥3)
  • Life expectancy <2 years
  • Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up

Sites / Locations

  • Soon Chun Hyang University Hospital BucheonRecruiting
  • Busan National University Yangsan HospitalRecruiting
  • Busan University HospitalRecruiting
  • Dong-A Medical CenterRecruiting
  • Soon Chun Hyang University Hospital CheonanRecruiting
  • Keimyung University Dongsan Medical CenterRecruiting
  • Chungnam National University HospitalRecruiting
  • Gangneung Asan Hospital
  • Chonnam National University HospitalRecruiting
  • Wonkwang University Hospital
  • Gachon University Gil Medical CenterRecruiting
  • Chonbuk National University HospitalRecruiting
  • Chungnam National University Sejong Hospital
  • Seoul university Bundang hospitalRecruiting
  • Asan Medical CenterRecruiting
  • Ewha Womans University Mokdong HospitalRecruiting
  • Kangdong KyungHee University hospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Korea University Guro Hospital
  • Seoul National University Boramae Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital
  • The Catholic Univ. of Korea, Seoul St. Mary's HospitalRecruiting
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICD implantation and optimal medical therapy

optimal medical therapy

Arm Description

Outcomes

Primary Outcome Measures

Death from any cause

Secondary Outcome Measures

Event rate of Cardiac death
Event rate of Death from arrhythmia
Event rate of Cardiac arrest
Event rate of Recurrence of ventricular tachyarrhythmia
Event rate of Hospitalization
Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia
Event rate of Appropriate ICD therapies
Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously
Event rate of Inappropriate ICD therapies
Event rate of Major device-related complications
Event rate of Stroke

Full Information

First Posted
July 24, 2016
Last Updated
June 22, 2023
Sponsor
Kee-joon Choi
Collaborators
CardioVascular Research Foundation, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT02845531
Brief Title
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Acronym
VARIANT ICD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
December 2029 (Anticipated)
Study Completion Date
June 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kee-joon Choi
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Variant, Sudden Cardiac Death
Keywords
Variant angina, Aborted sudden cardiac death, Implantable Cardioverter Defibrillator, Optimal Medical Therapy, ICD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICD implantation and optimal medical therapy
Arm Type
Experimental
Arm Title
optimal medical therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Implantable Cardioverter Defibrillator
Intervention Description
Implantable Cardioverter Defibrillator and Optimal Medical Therapy
Intervention Type
Drug
Intervention Name(s)
Optimal Medical Therapy
Primary Outcome Measure Information:
Title
Death from any cause
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Event rate of Cardiac death
Time Frame
5 years
Title
Event rate of Death from arrhythmia
Time Frame
5 years
Title
Event rate of Cardiac arrest
Time Frame
5 years
Title
Event rate of Recurrence of ventricular tachyarrhythmia
Time Frame
5 years
Title
Event rate of Hospitalization
Description
Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia
Time Frame
5 years
Title
Event rate of Appropriate ICD therapies
Description
Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously
Time Frame
5 years
Title
Event rate of Inappropriate ICD therapies
Time Frame
5 years
Title
Event rate of Major device-related complications
Time Frame
5 years
Title
Event rate of Stroke
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia Diagnosed as variant angina, defined by spontaneous coronary spasm with ST elevation (≥0.1mV) in the coronary angiogram and/or documented coronary spasm on ergonovine provocation coronary angiography Exclusion Criteria: Significant (>50%) coronary artery stenosis on coronary angiography Organic heart disease known to be associated with sudden cardiac arrest. Heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction < 35%) Presence of LV akinesia or aneurysm Hypertrophic cardiomyopathy Arrhythmogenic right ventricular dysplasia Chronic Heart Failure New York Heart Association functional class III or IV prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone) Prior catheter ablation for ventricular arrhythmia Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia) Prior pacemaker or Implantable Cardioverter Defibrillator 2nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker Patients with poor neurologic outcome (defined as cerebral performance category scale ≥3) Life expectancy <2 years Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kee-joon Choi, MD
Email
kjchoi@amc.seoul.kr
Facility Information:
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-woo Park, MD
First Name & Middle Initial & Last Name & Degree
Hyun-woo Park, MD
Facility Name
Busan National University Yangsan Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki-won Hwang, MD
Email
korea.hwang@gmail.com
First Name & Middle Initial & Last Name & Degree
Ki-won Hwang, MD
Facility Name
Busan University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-hee Ahn, MD
Email
reinee81@naver.com
First Name & Middle Initial & Last Name & Degree
Jin-hee Ahn, MD
Facility Name
Dong-A Medical Center
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-sung Park, MD
Email
thinkmed@naver.com
First Name & Middle Initial & Last Name & Degree
Jong-sung Park, MD
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se-whan Lee, MD
Email
Lovelee93@hanmail.net
First Name & Middle Initial & Last Name & Degree
Se-whan Lee, MD
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-wook Han, MD
Email
swhan@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
Sung-wook Han, MD
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-hyung Park, MD
First Name & Middle Initial & Last Name & Degree
Jae-hyung Park, MD
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-wook Park, MD
Email
mdhwp@chollian.net
First Name & Middle Initial & Last Name & Degree
Hyung-wook Park, MD
Facility Name
Wonkwang University Hospital
City
Iksan
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Hwan Han, MDD
Email
shhan@gilhospital.com
First Name & Middle Initial & Last Name & Degree
Seung-Hwan Han, MD
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung-seok Lee, MD
Email
ksee@jbnu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kyung-seok Lee, MD
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-whan Lee, MD
First Name & Middle Initial & Last Name & Degree
Jae-whan Lee, MD
Facility Name
Seoul university Bundang hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Il-young Oh, MD
First Name & Middle Initial & Last Name & Degree
Il-young Oh, MD
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kee-joon Choi, MD
Email
kjchoi@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Kee-joon Choi, MD
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Beom Park, MD
Email
parkjb@ewha.ac.kr
First Name & Middle Initial & Last Name & Degree
Jun-Beom Park, MD
Facility Name
Kangdong KyungHee University hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-sun Jin, MD
Email
eunsun.marcella@gmail.com
First Name & Middle Initial & Last Name & Degree
Eun-sun Jin, MD
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-hoon Kim, MD
Email
yhkmd@unitel.co.kr
First Name & Middle Initial & Last Name & Degree
Young-hoon Kim, MD
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo-hyun Lim, MD
Email
woosion@gmail.com
First Name & Middle Initial & Last Name & Degree
Woo-hyun Lim, MD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se-il Oh, MD
Email
seil@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Se-il Oh, MD
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-hwan Kim, MD
Email
sunghwan@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Sung-hwan Kim, MD
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death

We'll reach out to this number within 24 hrs