Clinical trial NCT02845531: Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Angina Pectoris, Variant
Sudden Cardiac Death
Keywords: Variant angina
Aborted sudden cardiac death
Implantable Cardioverter Defibrillator
Optimal Medical Therapy
ICD
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-07-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

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

Primary outcomes:
measure: Death from any cause
timeFrame: 5 years
Secondary outcomes:
measure: Event rate of Cardiac death
timeFrame: 5 years
measure: Event rate of Death from arrhythmia
timeFrame: 5 years
measure: Event rate of Cardiac arrest
timeFrame: 5 years
measure: Event rate of Recurrence of ventricular tachyarrhythmia
timeFrame: 5 years
measure: Event rate of Hospitalization
timeFrame: 5 years
measure: Event rate of Appropriate ICD therapies
timeFrame: 5 years
measure: Event rate of Inappropriate ICD therapies
timeFrame: 5 years
measure: Event rate of Major device-related complications
timeFrame: 5 years
measure: Event rate of Stroke
timeFrame: 5 years
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Busan
country: Korea, Republic of
facility: Busan National University Yangsan Hospital
city: Busan
country: Korea, Republic of
facility: Busan University Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul university Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong KyungHee University hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References: