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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

Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03383224
Enrollment
100
Registered
2017-12-26
Start date
2015-07-21
Completion date
2025-07-21
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Smoking Cessation

Keywords

smoking cessation treatment

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.

Interventions

OTHERgenotype-guided therapy

treatment based on patient's CHRNA5 rs16969968 genotype

DRUGNicotine patch
BEHAVIORALSmoking cessation counseling

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Randomized to genotype-guided therapy or standard of care

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking Cessation1 month after enrollmentNumber of participants no longer smoking as assessed by telephone-administered questionnaire

Secondary

MeasureTime frameDescription
Smoking Cessation6 months after enrollmentNumber of participants no longer smoking as assessed by telephone-administered questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026