Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00292032
Eligibility Criteria:
Inclusion Criteria:
* Cardiac arrest requiring cardioversion or defibrillation.
* Syncope with documented polymorphic ventricular tachycardia felt to be responsible for the index event.
* First degree relative of an index case of UCA undergoing clinical testing.
* First degree relative of a family member with UCA or sudden death before age 35 with a negative autopsy for cause of death, presumed arrhythmic.
* First degree relative of a family member with UCA or sudden death with objective evidence of primary electrical disease, such as a diagnostic electrocardiogram (ECG), exercise test, drug infusion, or genetic testing.
Exclusion Criteria:
* Coronary artery disease (stenosis \> 50%)
* Reduced left ventricular function (left ventricular ejection fraction \[LVEF\] \< 50%)
* Event managed without an implantable cardioverter defibrillator \[ICD\] (for follow-up portion)
* Unwilling or unable to provide clinical follow-up (for follow-up portion)
* Comorbidity making survival of \> 1 year unlikely
* Persistent resting QTc \> 460 msec for males and 480 msec for females
* Reversible cause of cardiac arrest such as marked hypokalemia (\< 2.8 mmol/l) or drug overdose sufficient in gravity without other cause to explain the cardiac arrest
* Hemodynamically stable sustained monomorphic ventricular tachycardia with a QRS morphology consistent with recognized forms of idiopathic ventricular tachycardia (outflow tract or apical septal)
* Brugada's sign with e2 mm ST elevation in V1 and/or V2
* Unwilling or unable to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00292032
Study Brief:
Protocol Section:
NCT00292032