PRISM-GENOMICS-Smoking Cessation for Patients With Coronary Artery Disease Undergoing Cardiac Catheterization or Having a Heart Attack at Barnes Hospital in St. Louis Mo

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS

Conditions
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Coronary Artery Disease, Smoking Cessation

Intervention / Treatment
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* Other: genotype-guided therapy
* Drug: Nicotine patch
* Behavioral: Smoking cessation counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) active smoker at time of presentation to Barnes Hospital participating in PRISM-GENOMICS observational study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to genotype-guided therapy or standard of care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotype-guided (A allele carriers)<br>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).) | Other: genotype-guided therapy<br>* treatment based on patient's CHRNA5 rs16969968 genotype<br>Drug: Nicotine patch<br> <br> |
| Experimental: Genotype-guided (GG homozygotes)<br>CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling) | Other: genotype-guided therapy<br>* treatment based on patient's CHRNA5 rs16969968 genotype<br>Behavioral: Smoking cessation counseling<br> <br> |
| Active Comparator: Standard (non-genotype guided) - NRT<br>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. | Drug: Nicotine patch<br> <br> |
| Active Comparator: Standard (non-genotype guided)- counseling<br>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. | Behavioral: Smoking cessation counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation | Number of participants no longer smoking as assessed by telephone-administered questionnaire | 1 month after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation | Number of participants no longer smoking as assessed by telephone-administered questionnaire | 6 months after enrollment | 
| Smoking Cessation | Number of participants no longer smoking as assessed by telephone-administered questionnaire | 12 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation treatment