Circulating Biomarkers and Ventricular Tachyarrhythmia

NCT ID: NCT01892462

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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

Conditions

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Cardiomyopathy Ventricular Tachycardia Ventricular Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

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Dr. Daniel P Morin, MD MPH FHRS

Cardiac Electrophysiologist, Director of Cardiovascular Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel P Morin, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Ochsner Medical Foundation

Locations

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Ochsner Health System

New Orleans, Louisiana, United States

Site Status

Countries

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United States

References

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Morin DP, Chong-Yik R, Thihalolipavan S, Krauthammer YS, Bernard ML, Khatib S, Polin GM, Rogers PA. Utility of serial measurement of biomarkers of cardiovascular stress and inflammation in systolic dysfunction. Europace. 2020 Jul 1;22(7):1044-1053. doi: 10.1093/europace/euaa075.

Reference Type DERIVED
PMID: 32357207 (View on PubMed)

Other Identifiers

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ISRCRM400003

Identifier Type: -

Identifier Source: org_study_id

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