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Trial record 7 of 2033 for:    Smoking Cessation

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

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ClinicalTrials.gov Identifier: NCT03383224
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sharon Cresci, Washington University School of Medicine

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : July 21, 2015
Estimated Primary Completion Date : July 21, 2025
Estimated Study Completion Date : July 21, 2025

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 1 month after enrollment ]
    Number of participants no longer smoking as assessed by telephone-administered questionnaire


Secondary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 6 months after enrollment ]
    Number of participants no longer smoking as assessed by telephone-administered questionnaire

  2. Smoking Cessation [ Time Frame: 12 months after enrollment ]
    Number of participants no longer smoking as assessed by telephone-administered questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383224


Contacts
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Contact: Sharon Cresci 3143625363 scresci@wustl.edu

Locations
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United States, Missouri
Barnes Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Sharon Cresci, MD         
Sponsors and Collaborators
Washington University School of Medicine

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Responsible Party: Sharon Cresci, Associate Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03383224     History of Changes
Other Study ID Numbers: 201412097
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sharon Cresci, Washington University School of Medicine:
smoking cessation treatment

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action