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Left Ventricular Structural Predictors of Sudden Cardiac Death

Recruitingn/aAges 21 Years - 80 YearsAllJohns Hopkins University
NCT01076660 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (\<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification. This project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they

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📋 Eligibility rules (as published)
Inclusion Criteria: * LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias) * Between the ages of 21 and 80 years old * Permission of the patient's clinical attending physician Exclusion Criteria: * Patients who refuse or are unable to give consent. * Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles) * Minors. * Pregnant women. * NYHA Class IV heart failure. * Chronic renal insufficiency with creatinine clearance\<60 ml/min; acute renal insufficiency of any severity * Claustrophobia * Prior adverse reaction to gadolinium-based contrast
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What it tests

  • Not listed
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Where

2 sites
Christiana Care Health Services
Newark, United States
Johns Hopkins Medical Institutions
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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