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Compares treatment options for Angina Pectoris, Variant
Official title Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
ClinicalTrials.gov ID: NCT02845531
What this study is testing
What is Optimal Medical Therapy?
Optimal Medical Therapy is an investigational medicine, being studied as a potential treatment for angina pectoris, variant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bucheon-si, South Korea
- Busan, South Korea
- Cheonan, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gangneung, South Korea
- Gwangju, South Korea
- Iksan, South Korea
- Ilsan, South Korea
- Incheon, South Korea
- Jeonju, South Korea
- Sejong, South Korea
- Seongnam, South Korea
- Seoul, South Korea
- Suwon, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bucheon-si, South Korea; Busan, South Korea; Cheonan, South Korea; Daegu, South Korea; Daejeon, South Korea; Gangneung, South Korea and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.