Clinical trial NCT03383224: 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
Official title: Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Smoking Cessation
Keywords: smoking cessation treatment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to genotype-guided therapy or standard of care
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Cessation
timeFrame: 1 month after enrollment
Secondary outcomes:
measure: Smoking Cessation
timeFrame: 6 months after enrollment
measure: Smoking Cessation
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Hospital
state: Missouri
Study officials:
References: