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Genotype-Guided Smoking Cessation Therapy for Coronary Artery Disease
N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult presenting to Barnes hospital cardiac catheterization laboratory with coronary artery disease or admitted to Barnes hospital within 24 hours of a type 1 myocardial infarction (heart attack)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after enrollment
Awards & highlights
Study Summary
This trial is testing whether using a person's genetic profile to guide smoking cessation treatment (nicotine replacement therapy) may help them quit smoking.
Who is the study for?
This trial is for adults with coronary artery disease undergoing cardiac catheterization or who have had a heart attack, and are active smokers. They must be able to consent, not incarcerated, stable post-heart attack without life-threatening complications, and women of child-bearing age should not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if nicotine patches and genotype-guided therapy can help patients quit smoking more effectively than standard treatments. Patients' genetic profiles determine their treatment plan in this randomized study.See study design
What are the potential side effects?
Nicotine patch use may cause skin irritation, dizziness, racing heartbeat, sleep problems or unusual dreams. Counseling has no physical side effects but discussing smoking cessation can sometimes cause emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was admitted to Barnes hospital for a heart attack or have coronary artery disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Smoking Cessation
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Genotype-guided (GG homozygotes)Experimental Treatment2 Interventions
CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)
Group II: Genotype-guided (A allele carriers)Experimental Treatment2 Interventions
CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (A allele carriers will be given pharmacologic therapy (nicotine replacement therapy --NRT; nicotine patch used according to FDA labelling).)
Group III: Standard (non-genotype guided) - NRTActive Control1 Intervention
1/2 of patients in this arm will be given nicotine replacement therapy (NRT; nicotine patch used according to FDA labeling) but this will NOT be based on the patient's genotype. Note that both nicotine replacement therapy and counseling are accepted treatments for smoking cessation in patients with coronary artery disease.
Group IV: Standard (non-genotype guided)- counselingActive Control1 Intervention
1/2 of patients in this arm will be given smoking cessation counseling but this will NOT be based on the patient's genotype. Note that both nicotine replacement therapy and counseling are accepted treatments for smoking cessation in patients with coronary artery disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smoking cessation counseling
2011
Completed Phase 4
~11390
Nicotine patch
2015
Completed Phase 4
~7450
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,609 Total Patients Enrolled
19 Trials studying Coronary Artery Disease
5,360 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was admitted to Barnes hospital for a heart attack or have coronary artery disease.I have had serious complications from a heart attack.I am unable to understand and give consent for treatment.I am currently unable to communicate verbally.You are in jail.You are already taking part in the PRISM-GENOMICS observational study.I am pregnant or breastfeeding.You are currently smoking when you come to Barnes Hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Genotype-guided (GG homozygotes)
- Group 2: Genotype-guided (A allele carriers)
- Group 3: Standard (non-genotype guided) - NRT
- Group 4: Standard (non-genotype guided)- counseling
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.
Is there currently an opportunity to sign up for participation in this experiment?
"This medical trial, which was first posted on July 21st 2015 and most recently updated October 28th 2021 is not presently seeking participants. However, there are 784 other clinical trials actively recruiting patients right now."
Answered by AI
How many participants are engaged in the trial?
"This experiment is not currently seeking any more participants. It was initially posted on July 21st 2015 and last updated October 28th 2021. Those who are looking for similar studies may consider the 713 trials recruiting patients with coronary artery disease or the 71 investigations enrolling individuals for genotype-guided therapy."
Answered by AI
What past experiences have there been with utilizing genotype-guided treatment approaches?
"Presently, there are 71 experiments pertaining to genotype-guided therapy in progress with 5 of them at Phase 3. While Greenville, South carolina has several clinical trials dedicated to this area of research, a total of 204 sites across the world are also conducting studies related to it."
Answered by AI
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