Left Ventricular Structural Predictors of Sudden Cardiac Death
Recruiting now
Conditions studied: Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy
In brief
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.
Key facts
- Study ID
- NCT01076660
- Run by
- Johns Hopkins University
- People needed
- 400
- Starts
- 2003-10-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-01-20
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Medical Institutions — Baltimore, Maryland, United States (enrolling)
- Christiana Care Health Services — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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