Left Ventricular Structural Predictors of Sudden Cardiac Death
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 indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD.
Conditions:
🦠 Ischemic Cardiomyopathy 🦠 Nonischemic Cardiomyopathy
🗓️ Study Start (Actual) October 2003
🗓️ Primary Completion (Estimated) June 2028
✅ Study Completion (Estimated) June 2030
👥 Enrollment (Estimated) 400
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Newark, Delaware, United States
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 February 2010
  • First Submitted that Met QC Criteria 25 February 2010
  • First Posted 26 February 2010

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 January 2024
  • Last Update Posted 12 January 2024
  • Last Verified January 2024