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Circulating Biomarkers and Ventricular Tachyarrhythmia (LIFEMARKER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01892462
First Posted: July 4, 2013
Last Update Posted: April 7, 2017
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.
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
July 1, 2013
July 4, 2013
April 7, 2017
June 2012
October 2016   (Final data collection date for primary outcome measure)
to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01892462 on ClinicalTrials.gov Archive Site
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Circulating Biomarkers and Ventricular Tachyarrhythmia
Circulating Biomarkers and Ventricular Tachyarrhythmia
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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood samples will be stored frozen for future analysis.
Non-Probability Sample

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.

  • Cardiomyopathy
  • Ventricular Tachycardia
  • Ventricular Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
October 2016
October 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01892462
ISRCRM400003
Yes
Not Provided
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Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
Ochsner Health System
Boston Scientific Corporation
Principal Investigator: Daniel P Morin, MD MPH Ochsner Medical Foundation
Ochsner Health System
April 2017