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Omega-3 Fatty Acid Supplement
Omega-3 Supplement (VASCAZEN) for Heart Disease (CARE Trial)
Phase 2
Waitlist Available
Led By Brian S Marino, DO
Research Sponsored by New York Hospital Queens
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights
CARE Trial Summary
This trial will test whether VASCAZEN, an omega-3 supplement, can help improve risk factors for heart disease in people who are already receiving rehabilitation for heart problems.
Who is the study for?
This trial is for adults over 18 with cardiovascular disease enrolled in a Cardiac Rehab clinic, who've had a heart check-up in the last 2 months. It's not for those with heart transplants, bleeding/clotting disorders, fish allergies, or taking omega-3 supplements. Pregnant women and those on hormone therapy can't join.Check my eligibility
What is being tested?
The study tests if VASCAZEN dietary supplement can correct omega-3 deficiency and improve risk factors in cardiac rehab patients with documented cardiovascular disease.See study design
What are the potential side effects?
VASCAZEN may cause side effects related to its fish oil content such as bad breath, heartburn, nausea, and loose stools. Allergic reactions could occur in individuals sensitive to fish.
CARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am enrolled in a Cardiac Rehab clinic for my heart disease.
CARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in sum of Omega-Score and Omega-Index
Secondary outcome measures
Change in patient health questionnaire-9 (PHQ-9) depression scale
Other outcome measures
Change in Lipoprotein associated Phospholipase (Lp-PLA2)
Change in Omega-3 Score and Omega-3 Index
Change in blood glucose and insulin measurements following administration of oral glucose tolerance test (OGTT)
+5 moreCARE Trial Design
1Treatment groups
Experimental Treatment
Group I: VascazenExperimental Treatment1 Intervention
Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks.
Find a Location
Who is running the clinical trial?
New York Hospital QueensLead Sponsor
6 Previous Clinical Trials
2,999 Total Patients Enrolled
Pivotal TherapeuticsUNKNOWN
NYHQ Cardiac Health CenterUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant nor planning to become pregnant.You have an allergy to fish.I have a known bleeding or clotting disorder.I am enrolled in a Cardiac Rehab clinic for my heart disease.I am currently on hormone replacement therapy.I am currently taking Omega-3 fatty acid supplements.I have had a heart transplant.I am willing to provide written consent.You have a heart device called an implantable cardiac defibrillator.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Vascazen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How has VASCAZEN been evaluated in terms of safety?
"Our team has rated VASCAZEN a 2 in terms of safety since it is still in Phase 2; while there are some indications that the drug may be safe, efficacy data is yet to be collected."
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