← Back to Search

ICD group for Sudden Cardiac Death

N/A
Waitlist Available
Led By Michael Orlov, MD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-month, 6-month, 9-month, and 12-month after icd therapy
Awards & highlights

Study Summary

Congestive heart failure (CHF) represents a major health care concern in the United States. Currently, risk stratification of sudden cardiac death and the need for implantable cardioverter-defibrillator (ICD) placement are essentially dependent upon assessment of left ventricular ejection fraction (LVEF). Nevertheless, the predictive value of LVEF is suboptimal, alternative testing for risk assessment for the development of sudden cardiac death in the heart failure population is desirable. At the genome level, the investigator has focused on the role of SCN5A gene mutations in arrhythmogenesis. Lymphocyte SCN5A mRNA processing may serve as a surrogate marker to assess SCN5A function at the cardiac level and may correlated with arrhythmic risk in high risk populations. This study will determine if SCN5A variant levels are predictive of appropriate ICD therapies in patients with a newly implanted ICD.

Eligible Conditions
  • Sudden Cardiac Death

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-month, 6-month, 9-month, and 12-month after icd therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-month, 6-month, 9-month, and 12-month after icd therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The levels of sodium channel splicing variants measured by gene expression that are related to arrhythmic events, change every 3 months from baseline to one 1 year after ICD therapy.
Secondary outcome measures
The levels of sodium channel splicing variants measured by gene expression that are related to the type of ICD implanted, change every 3 months from baseline to one 1 year after ICD therapy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICD groupExperimental Treatment1 Intervention
Adult patients with newly implanted ICD devices for primary prevention will be enrolled. At baseline, 3-, 6-, 9-, and 12-month followup visit, the medial information and blood samples will be collected.

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
66,557 Total Patients Enrolled
Michael Orlov, MDPrincipal InvestigatorRhode Island Hospital
1 Previous Clinical Trials
153 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~42 spots leftby Apr 2025