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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

NCT ID: NCT03383224

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-21

Study Completion Date

2025-07-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease Smoking Cessation

Keywords

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smoking cessation treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized to genotype-guided therapy or standard of care
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Genotype-guided (A allele carriers)

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).)

Group Type EXPERIMENTAL

genotype-guided therapy

Intervention Type OTHER

treatment based on patient's CHRNA5 rs16969968 genotype

Nicotine patch

Intervention Type DRUG

Genotype-guided (GG homozygotes)

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

Group Type EXPERIMENTAL

genotype-guided therapy

Intervention Type OTHER

treatment based on patient's CHRNA5 rs16969968 genotype

Smoking cessation counseling

Intervention Type BEHAVIORAL

Standard (non-genotype guided) - NRT

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.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

Standard (non-genotype guided)- 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.

Group Type ACTIVE_COMPARATOR

Smoking cessation counseling

Intervention Type BEHAVIORAL

Interventions

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genotype-guided therapy

treatment based on patient's CHRNA5 rs16969968 genotype

Intervention Type OTHER

Nicotine patch

Intervention Type DRUG

Smoking cessation counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sharon Cresci

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Barnes Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201412097

Identifier Type: -

Identifier Source: org_study_id