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

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ClinicalTrials.gov Identifier: NCT02052986
Recruitment Status : Unknown
Verified January 2014 by Brian S. Marino, DO, New York Hospital Queens.
Recruitment status was:  Not yet recruiting
First Posted : February 3, 2014
Last Update Posted : February 3, 2014
Sponsor:
Collaborators:
NYHQ Cardiac Health Center
Pivotal Therapeutics
Information provided by (Responsible Party):
Brian S. Marino, DO, New York Hospital Queens

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Other: VASCAZEN Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Estimated Primary Completion Date : January 2015

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Change in Omega-3 Score and Omega-3 Index [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  2. Change in high-sensitivity C-reactive protein (hsCRP) [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  3. 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 ]
  4. Change in blood level of Triglycerides [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  5. Change in fasting plasma glucose [ Time Frame: Baseline,12 weeks ]
  6. Change in blood glucose and insulin measurements following administration of oral glucose tolerance test (OGTT) [ Time Frame: Baseline, 12 weeks ]
  7. Change in glycated hemoglobin (HbA1c) [ Time Frame: Baseline,12 weeks ]
  8. Change in Lipoprotein associated Phospholipase (Lp-PLA2) [ Time Frame: Baseline, 6 weeks, 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02052986


Contacts
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Contact: Brian S Marino, DO 814-404-4169 brm9071@nyp.org
Contact: Donna Cheslik, RN, MSN 718-670-1695 djc9001@nyp.org

Locations
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United States, New York
The NYHQ Cardiac Health Center
Fresh Meadows, New York, United States, 11365
Contact: Brian Marino, DO    814-404-4169    brm9071@nyp.org   
Sub-Investigator: Todd Kerwin, MD         
Sub-Investigator: Barbara Pistone, RD         
Sponsors and Collaborators
New York Hospital Queens
NYHQ Cardiac Health Center
Pivotal Therapeutics
Investigators
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Principal Investigator: Brian S Marino, DO New York Hospital Queens
Additional Information:
WebMD  This link exits the ClinicalTrials.gov site

Publications:
Derosa G (2011) Effects of n-3 PUFA on Insulin Resistance After an Oral Fat Load. European Journal of Lipid Science. 113: (8) 950-960

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Responsible Party: Brian S. Marino, DO, Physician, New York Hospital Queens
ClinicalTrials.gov Identifier: NCT02052986    
Other Study ID Numbers: VCT-01
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014
Keywords provided by Brian S. Marino, DO, New York Hospital Queens:
Fatty Acids, Omega-3
Omega-3 fatty acids
Docosahexaenoic acid (DHA)
Eicosapentaenoic acid (EPA)
Docosapentaenoic acid (DPA)
Omega Index
Omega Score
Cardiac Rehab
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases