Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Smoking Cessation
研究概览
简要总结
It has previously been shown that patients with coronary artery disease may have a harder time quitting smoking if they have a specific genetic profile and that these individuals have a better chance at quitting if they receive nicotine replacement therapy. The investigators hypothesize that determining which individuals with coronary artery disease should receive nicotine replacement therapy based on their genotype may improve the number of individuals who are able to quit smoking.This study randomizes treatment to that determined by the patient's genotype compared to standard, non-genotype-guided, treatment.
详细描述
In this study, the investigators propose to show the feasibility of incorporating genotype-guided therapy into post-MI smoking cessation therapy and/or smoking cessation therapy in patients with coronary artery disease (CAD) using the CHRNA5 rs16969968 variant as the pilot case. The investigators propose to genotype ½ of PRISM-GENOMICs patients who are active smokers within 48 hours of admission and to guide their smoking cessation therapy based on CHRNA5 rs16969968 genotype (A allele carriers will be given pharmacologic therapy and GG homozygotes will be given counseling). The investigators will use the other ½ as controls. The participants will be followed and the investigators will test whether the genotype-guided group has better rates of smoking cessation compared to the control group. This pilot study will lay the foundation for personalized, genotype-guided, post-MI therapy and/or therapy in patients with CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •active smoker at time of presentation to Barnes Hospital
- •participating in PRISM-GENOMICS observational study
排除标准
- •Unable to provide informed consent
- •Unable to answer questions (e.g. intubated)
- •Incarcerated
- •Complications of myocardial infarction (such as shock, hemodynamic instability, life- threatening infection, etc)
- •Women of child-bearing age with positive pregnancy test or who is breast feeding
研究组 & 干预措施
Genotype-guided (A allele carriers)
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).)
干预措施: genotype-guided therapy (Other)
Genotype-guided (A allele carriers)
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).)
干预措施: Nicotine patch (Drug)
Genotype-guided (GG homozygotes)
CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)
干预措施: genotype-guided therapy (Other)
Genotype-guided (GG homozygotes)
CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)
干预措施: Smoking cessation counseling (Behavioral)
Standard (non-genotype guided) - NRT
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.
干预措施: Nicotine patch (Drug)
Standard (non-genotype guided)- counseling
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.
干预措施: Smoking cessation counseling (Behavioral)
结局指标
主要结局
Smoking Cessation
时间窗: 1 month after enrollment
Number of participants no longer smoking as assessed by telephone-administered questionnaire
次要结局
- Smoking Cessation(12 months after enrollment)
研究者
Sharon Cresci
Associate Professor of Medicine
Washington University School of Medicine