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

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

It had four arms (groups): Genotype-guided (A allele carriers) (experimental), Genotype-guided (GG homozygotes) (experimental), Standard (non-genotype guided) - NRT (active comparator) and Standard (non-genotype guided)- counseling (active comparator).

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

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.

The registry classes the interventions as behavioral, drug and other.

More on the Plan

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 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.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: unable to provide informed consent; unable to answer questions (e.g. intubated); complications of myocardial infarction (such as shock, hemodynamic instability, life- threatening infection, etc).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2015-07-21 with completion listed for 2025-07-21.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Smoking Cessation (time frame: 1 month after enrollment).

It also tracked 2 secondary outcomes, for example Smoking Cessation and Smoking Cessation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.