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

The Washington University

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Smoking Cessation

Treatments: Other: genotype-guided therapy; Behavioral: Smoking cessation counseling; Drug: Nicotine patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03383224

201412097

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Genotype-guided (A allele carriers)

Experimental group

Description:

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).)

Treatment:

Other: genotype-guided therapy

Drug: Nicotine patch

Genotype-guided (GG homozygotes)

Experimental group

Description:

CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)

Treatment:

Other: genotype-guided therapy

Behavioral: Smoking cessation counseling

Standard (non-genotype guided) - NRT

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine patch

Standard (non-genotype guided)- counseling

Active Comparator group

Description:

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:

Behavioral: Smoking cessation counseling