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Circulating Biomarkers and Ventricular Tachyarrhythmia (LIFEMARKER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01892462
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System

Tracking Information
First Submitted Date July 1, 2013
First Posted Date July 4, 2013
Last Update Posted Date April 7, 2017
Actual Study Start Date June 2012
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2013)
to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias. [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01892462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Circulating Biomarkers and Ventricular Tachyarrhythmia
Official Title Circulating Biomarkers and Ventricular Tachyarrhythmia
Brief 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.
Detailed 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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples will be stored frozen for future analysis.
Sampling Method Non-Probability Sample
Study Population

Patients with cardiomyopathy (left ventricular ejection fraction [LVEF] <=35%) who are followed at our institution's ICD device clinic will have levels of circulating biomarkers (hs-CRP, IL-6, TNF-alpha, IL-1, sST2, MMP-1, CICP, CITP) and BNP assessed at three-month intervals for at least one year. Patients will be excluded from the study if they have had a recent myocardial infarction or PCI (within three months), or recent hospitalization.

Patients with obvious primary inflammatory conditions (such as lupus and rheumatoid arthritis) will be excluded. Additionally, significant events (e.g., HF hospitalizations, revascularization, medication changes, and death) will be tracked at each follow up visit for further statistical analysis.

Condition
  • Cardiomyopathy
  • Ventricular Tachycardia
  • Ventricular Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 14, 2015)
220
Original Estimated Enrollment
 (submitted: July 3, 2013)
200
Actual Study Completion Date October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01892462
Other Study ID Numbers ISRCRM400003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
Study Sponsor Ochsner Health System
Collaborators Boston Scientific Corporation
Investigators
Principal Investigator: Daniel P Morin, MD MPH Ochsner Medical Foundation
PRS Account Ochsner Health System
Verification Date April 2017