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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03383224
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Smoking Cessation	Other: genotype-guided therapy; Drug: Nicotine patch; Behavioral: Smoking cessation counseling	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized to genotype-guided therapy or standard of careRandomized to genotype-guided therapy or standard of care
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS
• Actual Study Start Date: Jul 21, 2015
• Anticipated Primary Completion Date: Jul 21, 2025
• Anticipated Study Completion Date: Jul 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).)	Other: genotype-guided therapy; treatment based on patient's CHRNA5 rs16969968 genotype; Drug: Nicotine patch
Experimental: Genotype-guided (GG homozygotes) CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)	Other: genotype-guided therapy; treatment based on patient's CHRNA5 rs16969968 genotype; Behavioral: Smoking cessation counseling
Active Comparator: 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.	Drug: Nicotine patch
Active Comparator: 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.	Behavioral: Smoking cessation counseling

Outcome Measures

Primary Outcome Measures

1. Smoking Cessation [1 month after enrollment]

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

Secondary Outcome Measures

1. Smoking Cessation [6 months after enrollment]

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

2. Smoking Cessation [12 months after enrollment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnes Hospital	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sharon Cresci, Associate Professor of Medicine, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03383224
• Other Study ID Numbers: 201412097
• First Posted: Dec 26, 2017
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sharon Cresci, Associate Professor of Medicine, Washington University School of Medicine: smoking cessation treatment
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Nicotine

Study Results

No Results Posted as of Nov 1, 2021