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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
  Purpose
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.

Condition
Cardiomyopathy 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 Dr. Daniel P Morin, MD MPH FHRS, 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 ]

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

Enrollment: 220
Actual Study Start Date: June 2012
Study Completion Date: October 2016
Primary Completion Date: October 2016 (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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892462


Locations
United States, Louisiana
Ochsner Health System
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Boston Scientific Corporation
Investigators
Principal Investigator: Daniel P Morin, MD MPH Ochsner Medical Foundation
  More Information

Responsible Party: Dr. Daniel P Morin, MD MPH FHRS, Cardiac Electrophysiologist, Director of Cardiovascular Research, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01892462     History of Changes
Other Study ID Numbers: ISRCRM400003
First Submitted: July 1, 2013
First Posted: July 4, 2013
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Cardiomyopathies
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes