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NCT01892462 Clinical Trial

Circulating Biomarkers and Ventricular Tachyarrhythmia

Ventricular Tachycardia Clinical Trial

— LIFEMARKER  

Official title:
Circulating Biomarkers and Ventricular Tachyarrhythmia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01892462
Other study ID # ISRCRM400003
Secondary ID
Status Completed
Phase N/A
First received July 1, 2013
Last updated April 5, 2017
Start date June 2012
Est. completion date October 2016

Study information
Verified date April 2017
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether levels of inflammatory markers in circulating blood can correlate with risk for dangerous heart rhythms. Patients with systolic heart failure, which has been shown to increase risk for dangerous heart rhythms, will be enrolled. All subjects will have an implantable cardioverter-defibrillator (ICD) in place, which allows regular evaluation of heart rhythm.

Description:

If you agree to be in this study, you will be asked to the following things:

- you will come into the EP device clinic every three months for one year to have your device interrogated and will complete an EKG

- you will have labs drawn to measure levels of certain markers of inflammation in the body. This information will be used to identify new ways to test for risk of abnormal heart rhythms and other heart disease

- you will review your medications with the study coordinator and along with any recent illnesses or hospitalizations

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- left ventricular ejection fraction [LVEF] <=35%

- ICD implant

Exclusion Criteria:

- Recent myocardial infarction (12 weeks)

- Recent revascularization (12 weeks)

- Recent hospitalization for any cause (6 weeks)

- History of rheumatologic disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Ochsner Health System New Orleans Louisiana

Sponsors (2)
Lead Sponsor Collaborator
Ochsner Health System Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias. 1 year
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