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

Dyslipidemia Clinical Trial

— CARE  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02052986
• Other study ID #: VCT-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 16, 2013
• Last updated: January 31, 2014

Study information

• Verified date: January 2014
• Source: New York Hospital Queens
• Contact: Brian S Marino, DO
• Phone: 814-404-4169
• Email: brm9071[@]nyp.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Other:
• VASCAZEN
All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA

Locations

Country	Name	City	State
United States	The NYHQ Cardiac Health Center	Fresh Meadows	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York Hospital Queens	NYHQ Cardiac Health Center, Pivotal Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (11)

Albert CM, Campos H, Stampfer MJ, Ridker PM, Manson JE, Willett WC, Ma J. Blood levels of long-chain n-3 fatty acids and the risk of sudden death. N Engl J Med. 2002 Apr 11;346(15):1113-8. — View Citation

Bays H. Clinical overview of Omacor: a concentrated formulation of omega-3 polyunsaturated fatty acids. Am J Cardiol. 2006 Aug 21;98(4A):71i-76i. Epub 2006 May 30. Review. — View Citation

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

Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet. 1999 Aug 7;354(9177):447-55. Erratum in: Lancet 2001 Feb 24;357(9256):642. Lancet. 2007 Jan 13;369(9556):106. — View Citation

Geleijnse JM, Giltay EJ, Grobbee DE, Donders AR, Kok FJ. Blood pressure response to fish oil supplementation: metaregression analysis of randomized trials. J Hypertens. 2002 Aug;20(8):1493-9. — View Citation

Grimsgaard S, Bonaa KH, Hansen JB, Nordøy A. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am J Clin Nutr. 1997 Sep;66(3):649-59. — View Citation

Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. — View Citation

Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002 Nov 19;106(21):2747-57. Erratum in: Circulation. 2003 Jan 28;107(3):512.. — View Citation

Mori TA, Burke V, Puddey IB, Watts GF, O'Neal DN, Best JD, Beilin LJ. Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men. Am J Clin Nutr. 2000 May;71(5):1085-94. — View Citation

Thies F, Garry JM, Yaqoob P, Rerkasem K, Williams J, Shearman CP, Gallagher PJ, Calder PC, Grimble RF. Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaques: a randomised controlled trial. Lancet. 2003 Feb 8;361(9356):477-85. — View Citation

von Schacky C, Harris WS. Cardiovascular risk and the omega-3 index. J Cardiovasc Med (Hagerstown). 2007 Sep;8 Suppl 1:S46-9. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Omega-3 Score and Omega-3 Index		Baseline, 6 weeks, 12 weeks	No
Other	Change in high-sensitivity C-reactive protein (hsCRP)		Baseline, 6 weeks, 12 weeks	No
Other	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)		Baseline, 6 weeks, 12 weeks	No
Other	Change in blood level of Triglycerides		Baseline, 6 weeks, 12 weeks	No
Other	Change in fasting plasma glucose		Baseline,12 weeks	No
Other	Change in blood glucose and insulin measurements following administration of oral glucose tolerance test (OGTT)		Baseline, 12 weeks	No
Other	Change in glycated hemoglobin (HbA1c)		Baseline,12 weeks	No
Other	Change in Lipoprotein associated Phospholipase (Lp-PLA2)		Baseline, 6 weeks, 12 weeks	No
Primary	Change in sum of Omega-Score and Omega-Index	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	No
Secondary	Change in patient health questionnaire-9 (PHQ-9) depression scale	Change in patient health questionnaire-9 (PHQ-9) depression scale after 12 weeks of study treatment	12 weeks	No

External Links

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