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

NCT03383224 | Unknown DMC

• 1 other identifier: 201412097
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Smoking Cessation

Keywords

smoking cessation treatment

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation

  Number of participants no longer smoking as assessed by telephone-administered questionnaire

  1 month after enrollment

Secondary Outcomes (2)

• Smoking Cessation

  6 months after enrollment

• Smoking Cessation

  12 months after enrollment

Study Arms (4)

Genotype-guided (A allele carriers)

EXPERIMENTAL

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).)

Other: genotype-guided therapy; Drug: Nicotine patch

Genotype-guided (GG homozygotes)

EXPERIMENTAL

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

Other: genotype-guided therapy; Behavioral: Smoking cessation counseling

Standard (non-genotype guided) - NRT

ACTIVE COMPARATOR

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.

Drug: Nicotine patch

Standard (non-genotype guided)- counseling

ACTIVE COMPARATOR

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.

Behavioral: Smoking cessation counseling

Interventions

genotype-guided therapy OTHER

treatment based on patient's CHRNA5 rs16969968 genotype

Genotype-guided (A allele carriers); Genotype-guided (GG homozygotes)

Nicotine patch DRUG

Genotype-guided (A allele carriers); Standard (non-genotype guided) - NRT

Smoking cessation counseling BEHAVIORAL

Genotype-guided (GG homozygotes); Standard (non-genotype guided)- counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized to genotype-guided therapy or standard of care

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 26, 2017
• Study Start: July 21, 2015
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)