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| Name | Class |
|---|---|
| NYHQ Cardiac Health Center | UNKNOWN |
| Pivotal Therapeutics | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vascazen | Experimental | Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VASCAZEN | Other | All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Omega-3 Score and Omega-3 Index | Baseline, 6 weeks, 12 weeks | |
| Change in high-sensitivity C-reactive protein (hsCRP) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian S Marino, DO | Contact | 814-404-4169 | brm9071@nyp.org | |
| Donna Cheslik, RN, MSN | Contact | 718-670-1695 | djc9001@nyp.org |
| Name | Affiliation | Role |
|---|---|---|
| Brian S Marino, DO | New York Hospital Queens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The NYHQ Cardiac Health Center | Fresh Meadows | New York | 11365 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11948270 | Background | 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. doi: 10.1056/NEJMoa012918. | |
| 10465168 | Background | 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. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000601813 | VASCAZEN |
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| Baseline, 6 weeks, 12 weeks |
| Change in blood level of Triglycerides | Baseline, 6 weeks, 12 weeks |
| Change in fasting plasma glucose | Baseline,12 weeks |
| Change in blood glucose and insulin measurements following administration of oral glucose tolerance test (OGTT) | Baseline, 12 weeks |
| Change in glycated hemoglobin (HbA1c) | Baseline,12 weeks |
| Change in Lipoprotein associated Phospholipase (Lp-PLA2) | Baseline, 6 weeks, 12 weeks |
| 16919519 | Background | 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. doi: 10.1016/j.amjcard.2005.12.029. Epub 2006 May 30. |
| 10799369 | Background | 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. doi: 10.1093/ajcn/71.5.1085. |
| 9280188 | Background | Grimsgaard S, Bonaa KH, Hansen JB, Nordoy 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. doi: 10.1093/ajcn/66.3.649. |
| 12172309 | Background | 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. doi: 10.1097/00004872-200208000-00010. |
| 12583947 | Background | 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. doi: 10.1016/S0140-6736(03)12468-3. |
| 12438303 | Background | 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. doi: 10.1161/01.cir.0000038493.65177.94. No abstract available. |
| 15208005 | Background | 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. doi: 10.1016/j.ypmed.2004.02.030. |
| 17876200 | Background | von Schacky C, Harris WS. Cardiovascular risk and the omega-3 index. J Cardiovasc Med (Hagerstown). 2007 Sep;8 Suppl 1:S46-9. doi: 10.2459/01.JCM.0000289273.87803.87. |
| Background | 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 |