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

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ClinicalTrials.gov Identifier: NCT02845531
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Kee-joon Choi, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Angina Pectoris, Variant Sudden Cardiac Death Device: Implantable Cardioverter Defibrillator Drug: Optimal Medical Therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Experimental: ICD implantation and optimal medical therapy Device: Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator and Optimal Medical Therapy

Active Comparator: optimal medical therapy Drug: Optimal Medical Therapy



Primary Outcome Measures :
  1. Death from any cause [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Event rate of Cardiac death [ Time Frame: 5 years ]
  2. Event rate of Death from arrhythmia [ Time Frame: 5 years ]
  3. Event rate of Cardiac arrest [ Time Frame: 5 years ]
  4. Event rate of Recurrence of ventricular tachyarrhythmia [ Time Frame: 5 years ]
  5. Event rate of Hospitalization [ Time Frame: 5 years ]
    Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia

  6. Event rate of Appropriate ICD therapies [ Time Frame: 5 years ]
    Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously

  7. Event rate of Inappropriate ICD therapies [ Time Frame: 5 years ]
  8. Event rate of Major device-related complications [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02845531


Contacts
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Contact: Kee-joon Choi, MD kjchoi@amc.seoul.kr

Locations
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Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Active, not recruiting
Bucheon, Korea, Republic of
Busan National University Yangsan Hospital Active, not recruiting
Busan, Korea, Republic of
Busan University Hospital Recruiting
Busan, Korea, Republic of
Contact: Jin-hee Ahn, MD       reinee81@naver.com   
Principal Investigator: Jin-hee Ahn, MD         
Dong-A Medical Center Recruiting
Busan, Korea, Republic of
Contact: Jong-sung Park, MD       thinkmed@naver.com   
Principal Investigator: Jong-sung Park, MD         
Soon Chun Hyang University Hospital Cheonan Recruiting
Cheonan, Korea, Republic of
Contact: Se-whan Lee, MD       Lovelee93@hanmail.net   
Principal Investigator: Se-whan Lee, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Sung-wook Han, MD       swhan@dsmc.or.kr   
Principal Investigator: Sung-wook Han, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae-whan Lee, MD       myheart@cnu.ac.kr   
Principal Investigator: Jae-whan Lee, MD         
Gangneung Asan Hospital Withdrawn
Gangneung, Korea, Republic of
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Hyung-wook Park, MD       mdhwp@chollian.net   
Principal Investigator: Hyung-wook Park, MD         
Wonkwang University Hospital Withdrawn
Iksan, Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Seung-Hwan Han, MDD       shhan@gilhospital.com   
Principal Investigator: Seung-Hwan Han, MD         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Kyung-seok Lee, MD       ksee@jbnu.ac.kr   
Principal Investigator: Kyung-seok Lee, MD         
Seoul university Bundang hospital Recruiting
Seongnam, Korea, Republic of
Contact: Young-jin Cho, MD       yino.md@gmail.com   
Principal Investigator: Young-jin Cho, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kee-joon Choi, MD       kjchoi@amc.seoul.kr   
Principal Investigator: Kee-joon Choi, MD         
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jun-Beom Park, MD       parkjb@ewha.ac.kr   
Principal Investigator: Jun-Beom Park, MD         
Kangdong KyungHee University hospital Active, not recruiting
Seoul, Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young-hoon Kim, MD       yhkmd@unitel.co.kr   
Principal Investigator: Young-hoon Kim, MD         
Korea University Guro Hospital Active, not recruiting
Seoul, Korea, Republic of
Seoul National University Boramae Medical Center Active, not recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Se-il Oh, MD       seil@snu.ac.kr   
Principal Investigator: Se-il Oh, MD         
Severance Hospital Active, not recruiting
Seoul, Korea, Republic of
The Catholic Univ. of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang-hong Baek, MD       whitesh@catholic.ac.kr   
Principal Investigator: Sang-hong Baek, MD         
Ajou University Hospital Active, not recruiting
Suwon, Korea, Republic of
Sponsors and Collaborators
Kee-joon Choi
CardioVascular Research Foundation, Korea

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Responsible Party: Kee-joon Choi, professor of medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02845531     History of Changes
Other Study ID Numbers: AMCCV2016-15
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
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

Keywords provided by Kee-joon Choi, Asan Medical Center:
Variant angina
Aborted sudden cardiac death
Implantable Cardioverter Defibrillator
Optimal Medical Therapy
ICD

Additional relevant MeSH terms:
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Death
Angina Pectoris
Death, Sudden, Cardiac
Angina Pectoris, Variant
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Heart Arrest
Death, Sudden
Angina, Unstable