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

Launched by KEE-JOON CHOI · Jul 24, 2016

Keywords

ClinConnect Summary

This clinical trial is studying whether adding an Implantable Cardioverter Defibrillator (ICD) to the best medical treatment can help prevent death in patients who have experienced a sudden cardiac event due to variant angina. Variant angina is a type of chest pain caused by temporary spasms in the coronary arteries, which can lead to serious heart problems. The trial aims to find out if using an ICD, which is a device that can correct dangerous heart rhythms, is more effective in saving lives compared to just using medication.

To participate in this study, you must be at least 18 years old and have had a cardiac arrest that was successfully treated, specifically due to a dangerous heart rhythm called ventricular fibrillation or sustained rapid ventricular tachycardia. You also need to have a diagnosis of variant angina. However, there are certain conditions that would exclude you from the trial, such as having significant blockages in your coronary arteries or other serious heart diseases. If eligible, participants can expect close monitoring and follow-up as part of the study. This trial is currently recruiting participants of all genders, aged 18 and older.

Gender

ALL

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