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

Coronary Artery Disease Clinical Trial

Official title:

Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03383224
• Other study ID #: 201412097
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2015
• Est. completion date: July 21, 2025

Study information

• Verified date: October 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 21, 2025
• Est. primary completion date: July 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Smoking Cessation

Intervention

Other:
• genotype-guided therapy
treatment based on patient's CHRNA5 rs16969968 genotype

Drug:
• Nicotine patch

Behavioral:
• Smoking cessation counseling

Locations

Country	Name	City	State
United States	Barnes Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation	Number of participants no longer smoking as assessed by telephone-administered questionnaire	1 month after enrollment
Secondary	Smoking Cessation	Number of participants no longer smoking as assessed by telephone-administered questionnaire	6 months after enrollment
Secondary	Smoking Cessation	Number of participants no longer smoking as assessed by telephone-administered questionnaire	12 months after enrollment