An Open-Label Study of Vascazen in Cardiac Rehab Patients With Deficient Blood Omega-3 Fatty Acid Levels (CARE)

January 31, 2014 updated by: Brian S. Marino, DO, New York Hospital Queens
The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Fresh Meadows, New York, United States, 11365
        • The NYHQ Cardiac Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects (> or = 18 years of age)
  • Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator
  • Has had cardiovascular examination within the past 2 months

Exclusion Criteria:

  • Subjects who refuse to provide written consent
  • Subjects with medical conditions, as determined by the principal investigator, which prevented them from study participation
  • Subjects with a known bleeding or clotting disorder
  • Subjects with known allergies to fish
  • Subjects with an implantable cardiac defibrillator
  • Subjects with a heart transplant
  • Female subjects who are currently taking hormone replacement therapy
  • Subjects who are pregnant or planning on becoming pregnant
  • Subjects currently taking Omega-3 fatty acid supplements (either under medical supervision or self-administered)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vascazen
Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks.
Other: VASCAZEN
All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sum of Omega-Score and Omega-Index
Time Frame: 12 weeks
Change in the sum of the subject's blood Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) + Docosapentaenoic acid (DPA) levels (Omega-Score) and the change in the sum of the subject's red blood cell (RBC) EPA + DHA levels (Omega-Index) over 12 weeks of study treatment with Vascazen
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient health questionnaire-9 (PHQ-9) depression scale
Time Frame: 12 weeks
Change in patient health questionnaire-9 (PHQ-9) depression scale after 12 weeks of study treatment
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change in Omega-3 Score and Omega-3 Index
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
Change in high-sensitivity C-reactive protein (hsCRP)
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
Change in blood levels of total cholesterol, low-density lipoprotein (LDL), high density lipoprotein (HDL), very-low density lipoprotein (VLDL) cholesterol and their subfractions (particle size)
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
Change in blood level of Triglycerides
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks
Change in fasting plasma glucose
Time Frame: Baseline,12 weeks
Baseline,12 weeks
Change in blood glucose and insulin measurements following administration of oral glucose tolerance test (OGTT)
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks
Change in glycated hemoglobin (HbA1c)
Time Frame: Baseline,12 weeks
Baseline,12 weeks
Change in Lipoprotein associated Phospholipase (Lp-PLA2)
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Hospital Queens

Collaborators

NYHQ Cardiac Health Center
Pivotal Therapeutics

Investigators

  • Principal Investigator: Brian S Marino, DO, New York Hospital Queens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Estimate)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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