search
Back to results

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

Primary Purpose

Coronary Artery Disease, Smoking Cessation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
genotype-guided therapy
Nicotine patch
Smoking cessation counseling
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring smoking cessation treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnes Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Genotype-guided (A allele carriers)

Genotype-guided (GG homozygotes)

Standard (non-genotype guided) - NRT

Standard (non-genotype guided)- counseling

Arm Description

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).)

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2017
Last Updated
October 28, 2021
Sponsor
Washington University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03383224
Brief Title
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
Official Title
Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2015 (Actual)
Primary Completion Date
July 21, 2025 (Anticipated)
Study Completion Date
July 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Smoking Cessation
Keywords
smoking cessation treatment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized to genotype-guided therapy or standard of care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genotype-guided (A allele carriers)
Arm Type
Experimental
Arm Description
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).)
Arm Title
Genotype-guided (GG homozygotes)
Arm Type
Experimental
Arm Description
CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)
Arm Title
Standard (non-genotype guided) - NRT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard (non-genotype guided)- counseling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
genotype-guided therapy
Intervention Description
treatment based on patient's CHRNA5 rs16969968 genotype
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation counseling
Primary Outcome Measure Information:
Title
Smoking Cessation
Description
Number of participants no longer smoking as assessed by telephone-administered questionnaire
Time Frame
1 month after enrollment
Secondary Outcome Measure Information:
Title
Smoking Cessation
Description
Number of participants no longer smoking as assessed by telephone-administered questionnaire
Time Frame
6 months after enrollment
Title
Smoking Cessation
Description
Number of participants no longer smoking as assessed by telephone-administered questionnaire
Time Frame
12 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Barnes Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs