- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383224
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
October 28, 2021 updated by: Sharon Cresci, Washington University School of Medicine
Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Barnes Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).)
|
treatment based on patient's CHRNA5 rs16969968 genotype
|
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)
|
treatment based on patient's CHRNA5 rs16969968 genotype
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Cessation
Time Frame: 1 month after enrollment
|
Number of participants no longer smoking as assessed by telephone-administered questionnaire
|
1 month after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Cessation
Time Frame: 6 months after enrollment
|
Number of participants no longer smoking as assessed by telephone-administered questionnaire
|
6 months after enrollment
|
Smoking Cessation
Time Frame: 12 months after enrollment
|
Number of participants no longer smoking as assessed by telephone-administered questionnaire
|
12 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2015
Primary Completion (Anticipated)
July 21, 2025
Study Completion (Anticipated)
July 21, 2025
Study Registration Dates
First Submitted
December 12, 2017
First Submitted That Met QC Criteria
December 21, 2017
First Posted (Actual)
December 26, 2017
Study Record Updates
Last Update Posted (Actual)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 28, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 201412097
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
Clinical Trials on Nicotine patch
-
McNeil ABCompleted
-
Vanderbilt University Medical CenterCompletedDown Syndrome | Mild Cognitive ImpairmentUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedTobacco Use DisorderUnited States
-
National Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Tobacco Use Disorder | Schizophrenia and Disorders With Psychotic FeaturesUnited States
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedNicotine DependenceUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedBreast Cancer | Colorectal Cancer | Tobacco Use Disorder | Lung Cancer | Prostate CancerUnited States
-
McNeil ABCompleted
-
Massachusetts General HospitalStanley Medical Research Institute; North Suffolk Mental Health AssociationCompleted
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletedKidney Cancer | Cervical Cancer | Leukemia | Head and Neck Cancer | Gastric Cancer | Pancreatic Cancer | Esophageal Cancer | Tobacco Use Disorder | Lung Cancer | Bladder Cancer | Liver CancerUnited States