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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype-guided (A allele carriers) | Experimental | 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).) |
|
| Genotype-guided (GG homozygotes) | Experimental | CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling) |
|
| Standard (non-genotype guided) - NRT | Active Comparator | 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. |
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| Standard (non-genotype guided)- counseling | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genotype-guided therapy | Other | treatment based on patient's CHRNA5 rs16969968 genotype |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | Number of participants no longer smoking as assessed by telephone-administered questionnaire | 1 month after enrollment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Hospital | St Louis | Missouri | 63110 | United States |
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Randomized to genotype-guided therapy or standard of care
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| Nicotine patch | Drug |
|
| Smoking cessation counseling | Behavioral |
|
| 12 months after enrollment |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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