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

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease; Smoking Cessation
• Interventions: Other: genotype-guided therapy; Drug: Nicotine patch; Behavioral: Smoking cessation counseling

• Registration Number: NCT03383224
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07-21
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01
• Primary Completion: 2025-07-21
• Study Completion: 2025-07-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotype-guided (A allele carriers)	genotype-guided therapy	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)	Smoking cessation counseling	CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)
Genotype-guided (GG homozygotes)	genotype-guided therapy	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	Nicotine patch	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.
Genotype-guided (A allele carriers)	Nicotine patch	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).)
Standard (non-genotype guided)- counseling	Smoking cessation 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.

Primary Outcome Measures

Name	Time	Method
Smoking Cessation	1 month after enrollment	Number of participants no longer smoking as assessed by telephone-administered questionnaire

Secondary Outcome Measures

Name	Time	Method
Smoking Cessation	12 months after enrollment	Number of participants no longer smoking as assessed by telephone-administered questionnaire

Trial Locations

Locations (1)

Barnes Hospital; 🇺🇸 Saint Louis, Missouri, United States