Circulating Biomarkers and Ventricular Tachyarrhythmia (LIFEMARKER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Ochsner Health System
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System Identifier:
First received: July 1, 2013
Last updated: October 14, 2015
Last verified: October 2015
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.

Ventricular Tachycardia
Ventricular Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Biomarkers and Ventricular Tachyarrhythmia

Resource links provided by NLM:

Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood samples will be stored frozen for future analysis.

Estimated Enrollment: 220
Study Start Date: June 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01892462

United States, Louisiana
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Daniel P Morin, MD    504-842-5059   
Principal Investigator: Daniel P Morin, MD MPH         
Sponsors and Collaborators
Ochsner Health System
Boston Scientific Corporation
Principal Investigator: Daniel P Morin, MD MPH Ochsner Medical Foundation
  More Information

No publications provided

Responsible Party: Dr. Daniel P Morin, MD MPH FHRS, Cardiac Electrophysiologist, Director of Cardiovascular Research, Ochsner Health System Identifier: NCT01892462     History of Changes
Other Study ID Numbers: ISRCRM400003
Study First Received: July 1, 2013
Last Updated: October 14, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on November 27, 2015