Left Ventricular Structural Predictors of Sudden Cardiac Death

Description

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 Overview

Study Details

Study overview

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.

Left Ventricular Structural Predictors of Sudden Cardiac Death [Substudy of: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death, See Also NCT000181233]

Left Ventricular Structural Predictors of Sudden Cardiac Death

Condition
Ischemic Cardiomyopathy
Intervention / Treatment

-

Contacts and Locations

Newark

Christiana Care Health Services, Newark, Delaware, United States, 19718

Baltimore

Johns Hopkins Medical Institutions, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Katherine Wu, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Robert G Weiss, MD, STUDY_DIRECTOR, Johns Hopkins University

Study Record Dates

2030-06