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Cancer Vaccine
Grape Powder for Atrial Fibrillation
Phase 1 & 2
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial proposes to use a natural substance (found in grapes) to prevent a common complication of cardiac surgery (POAF) which can lead to worse outcomes.
Who is the study for?
This trial is for men and women aged 50-79 who are undergoing elective cardiac surgery for mitral valve repair but not the Cox MAZE procedure. Candidates should be in normal heart rhythm with no history of atrial fibrillation, previous cardiac surgeries, or use of certain medications like corticosteroids and antiarrhythmics. Smokers and those with specific heart risks or autoimmune diseases cannot participate.Check my eligibility
What is being tested?
The study tests if preoperative administration of concentrated grape powder can prevent post-operative atrial fibrillation (POAF), a common complication after heart surgery linked to inflammation. Participants will receive either the grape powder or a placebo to compare effectiveness.See study design
What are the potential side effects?
Since the intervention involves grape powder, which is expected to have minimal side effects due to its natural origin, any potential side effects are likely mild compared to pharmaceuticals. However, individual reactions may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II
POAF-related events during initial hospital stay and within 30 days after surgery
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Concentrated grape powderExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
California Table Grape CommissionOTHER
6 Previous Clinical Trials
157 Total Patients Enrolled
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,866 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,212 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an autoimmune disease.I have a weak heart pump, a large left atrium, or severe valve leakage.I have had heart surgery in the past.I have an active infection, inflammation, or another type of cancer.I am 80 years old or older.I am between 50-79 years old and having elective surgery for mitral valve repair without Cox MAZE, but possibly with CABG or tricuspid valve repair.I have been diagnosed with chronic or occasional atrial fibrillation before surgery.I have had a procedure to treat atrial fibrillation.You are currently smoking.I am not taking steroids or medications that affect my immune system.I am taking medication for irregular heartbeats.You have a pacemaker implanted.You have other health conditions, like heart problems that required surgery.Your heart is beating normally without any irregular rhythm.
Research Study Groups:
This trial has the following groups:- Group 1: Concentrated grape powder
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Does the clinical trial accept individuals above a certain age threshold?
"This trial is open to individuals aged between 18 and 79 years old, while 11 other clinical trials are available for minors and 495 studies have been designed for elderly people over the age of 65."
Answered by AI
Does this research project presently accept new participants?
"Per the information on clinicaltrials.gov, this particular trial is not presently seeking participants. This study was initially posted in September of 2023 and edited for the last time in August of that same year. Despite its current inactive state, there are still 498 other trials actively recruiting volunteers at this moment."
Answered by AI
Are there any criteria that must be met for eligibility in this clinical research?
"To be considered eligible for this trial, individuals must possess atrial fibrillation and fall between the ages of 18-79. Approximately 70 persons are being sought out to participate in this research."
Answered by AI
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