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Search / Trial NCT01076660

Left Ventricular Structural Predictors of Sudden Cardiac Death

Launched by JOHNS HOPKINS UNIVERSITY · Feb 25, 2010

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Ischemic Cardiomyopathy Nonischemic Cardiomyopathy Implantable Cardioverter Defibrillator Sudden Cardiac Death Ventricular Tachycardia Ventricular Fibrillation

ClinConnect Summary

This clinical trial is studying the risk of sudden cardiac death (SCD) in patients with weakened heart function, specifically looking at how the structure of the heart itself can help predict this risk. Researchers believe that certain abnormalities in the heart's structure might indicate a higher risk of dangerous heart rhythms that can lead to SCD. By using advanced imaging techniques, like cardiac magnetic resonance imaging (MRI), along with other health factors, the study aims to improve the ability to identify patients who might benefit from implantable cardioverter defibrillators (ICDs), devices that can help prevent SCD.

To participate in this trial, individuals should be between 21 and 80 years old with a specific type of heart dysfunction (known as left ventricular ejection fraction ≤35%) and have been referred for ICD insertion to prevent future heart issues. Participants will undergo MRI scans to assess their heart structure and may receive additional tests or evaluations during the study. It's important to note that some individuals, such as those with certain medical conditions or who have a fear of enclosed spaces (claustrophobia), may not be eligible to participate. Overall, this trial aims to refine how we determine who is at risk for sudden cardiac death, ultimately leading to better care for patients with heart conditions.

Gender

ALL

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

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Newark, Delaware, United States

Baltimore, Maryland, United States

Patients applied

VW

1 patients applied

Trial Officials

Katherine Wu, MD

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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