NCT01076660 Left Ventricular Structural Predictors of Sudden Cardiac Death
| NCT ID | NCT01076660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Ischemic Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2003-10 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2003-10 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Katherine Wu, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT01076660 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Ischemic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01076660 currently recruiting?
Yes, NCT01076660 is actively recruiting participants. Contact the research team at kwu@jhmi.edu for enrollment information.
Where is the NCT01076660 trial being conducted?
This trial is being conducted at Newark, United States, Baltimore, United States.
Who is sponsoring the NCT01076660 clinical trial?
NCT01076660 is sponsored by Johns Hopkins University. The principal investigator is Katherine Wu, MD at Johns Hopkins University. The trial plans to enroll 400 participants.