Post Acute Cardiac Event Smoking (PACES) Study

Acute Coronary Syndrome Clinical Trial

Official title:

Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03413423
• Other study ID #: 17-4375
• Secondary ID: 1R01HL136327
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2023
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Summary of the Project : Quitting smoking following acute coronary syndrome (ACS) can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). Objective: For this R01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (BAT-CS).

Description:

This project will implement a fully powered efficacy trial enrolling 324 smokers with ACS and randomize them to 12 weeks of either Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) or control condition (including contact match). BAT-CS interventions will focus on smoking cessation and mood management, while the control condition will focus on smoking cessation and general health education. Both groups will be offered the nicotine patch if medically safe. Follow-up assessments will be conducted at end-of-treatment (12 weeks post-discharge for index event), and 6, 9, and 12 months after hospital discharge. The occurrence of major adverse cardiac events and all-cause mortality will be tracked for up to 60 months post discharge.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 233
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• hospital inpatients with an ACS diagnosis documented in medical record within the past 30 days
• smoked equal or greater than 1 cigarette per day before being hospitalized
• age of 18-75 years
• English fluency
• willing to consider quitting smoking at discharge
• has a telephone or is willing to use a study issued cell phone
• willing to consent to all study procedures.

Exclusion Criteria:

• limited mental competency
• presence of severe mental illness that would interfere with participation or suicidality
• expected discharge to hospice or greater than 50% chance of 6 month mortality per risk calculator
• currently attending counseling for depression or smoking cessation.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome
• Tobacco Use

Intervention

Behavioral:
• BAT-CS
All participants will receive one hour standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.
• Smoking Cessation and Health & Wellness
All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking Cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Minneapolis Heart Institute Foundation, National Heart, Lung, and Blood Institute (NHLBI), The Miriam Hospital, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence from smoking	Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed with saliva cotinine or by carbon monoxide in a breath sample	12 Months
Primary	Depression Symptoms	The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.	12 Months
Secondary	Continuous Abstinence From Smoking Since Hospital Discharge	No smoking, not even a puff, since hospital discharge	12 Months
Secondary	Time to Smoking Relapse	Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing.	12 Months
Secondary	Time to Smoking Lapse	Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.	12 Months
Secondary	Depressed mood	10 Item Center for Epidemiologic Studies Depression Scale (CESD)	The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
Secondary	Positive Affect	As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect.	12 Months
Secondary	Negative Affect	As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.	12 Months
Secondary	Systolic and Diastolic Blood Pressure	Resting Systolic and Diastolic Blood Pressure	12 Months
Secondary	Blood Bio-markers	HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen	12 Months
Secondary	Major adverse cardiac events (MACE) and all cause mortality	Time in days to MACE or all cause mortality. MACE = non-fatal myocardial infarction (using standard American Heart Association definitions), hospitalization for unstable angina, or urgent coronary revascularization.	5 years
Secondary	Health Related Quality of Life	12-Item Short Form Health Survey (SF-12)	12 Months
Secondary	Treatment Acceptability	Client Satisfaction Questionnaire	12 weeks