Acute Coronary SyndromeNCT03413423
Post Acute Cardiac Event Smoking (PACES) Study
A study testing BAT-CS and Smoking Cessation and Health & Wellness in people with Acute Coronary Syndrome and Tobacco Use, run by Hennepin Healthcare Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Tobacco Use
- What is being tested?
- BAT-CS and Smoking Cessation and Health & Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2018to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
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).
Read the detailed 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.
- Conditions
- Acute Coronary Syndrome, Tobacco Use
- Being tested
- BAT-CS, Smoking Cessation and Health & Wellness
- Keywords
- smoking, depression, Behavioral Activation, Mood management, Secondary Prevention
- Medical subject headings
- Acute Coronary Syndrome, Tobacco Use, Smoking, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT-CSBehavioural
Also called Smoking Cessation and Mood Management
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 & WellnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BAT-CS | Experimental | Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. Receives: Behavioral: BAT-CS |
| Smoking Cessation and Health & Wellness | Active comparator | Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared. Receives: Behavioral: Smoking Cessation and Health & Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Depression Symptoms
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
Measured: 12 Months
Secondary outcomes (11)
Continuous Abstinence From Smoking Since Hospital Discharge
No smoking, not even a puff, since hospital discharge
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
Depressed mood
10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Measured: The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
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.
Measured: 12 Months
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.
Measured: 12 Months
Systolic and Diastolic Blood Pressure
Resting Systolic and Diastolic Blood Pressure
Measured: 12 Months
Blood Bio-markers
HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen
Measured: 12 Months
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.
Measured: 5 years
Health Related Quality of Life
12-Item Short Form Health Survey (SF-12)
Measured: 12 Months
Treatment Acceptability
Client Satisfaction Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start29 Jan 2018
- Primary completion8 May 2024
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Minneapolis Heart Institute Foundation, The Miriam Hospital, National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota
- Responsible party
- Principal investigator, Andrew Busch, Hennepin Healthcare Research Institute
- Investigators
- Andrew Busch, PhD, Principal investigator, Senior Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413423
- Sponsor's protocol ID
- 17-4375
- Other IDs
- 1R01HL136327
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2018
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Completely de-identified data (i.e.,data that has been cleaned of all 18 types of HIPAA identifiers) will be available to other qualified researchers. Within 18 months of study completion, we will make datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely). The NIH will be notified of transmissions of the data to interested investigators.
Publications
Adkins-Hempel M, Japuntich SJ, Chrastek M, Dunsiger S, Breault CE, Ayenew W, Everson-Rose SA, Nijjar PS, Bock BC, Wu WC, Miedema MD, Carlson BM, Busch AM. Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial. Addict Sci Clin Pract. 2023 May 12;18(1):29. doi: 10.1186/s13722-023-00388-9.
PubMed 37173792Ajayi AA, Adkins-Hempel M, Breault C, Ayenew W, Everson-Rose SA, Japuntich SJ, Dunsiger SI, Busch AM. Racial Disparities in Biopsychosocial Predictors of Short-Term Smoking Cessation Following Acute Coronary Syndrome Hospitalization. J Racial Ethn Health Disparities. 2026 Apr 17. doi: 10.1007/s40615-026-02940-0. Online ahead of print.
PubMed 41995991
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
- ClinicalTrials.gov ID
- NCT03413423
- Acronym / sponsor ID
- 17-4375
- Conditions
- Acute Coronary Syndrome, Tobacco Use
- Keywords
- smoking, depression, Behavioral Activation, Mood management, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- Minneapolis Heart Institute Foundation, The Miriam Hospital, National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAT-CS | Experimental | Behavioral: BAT-CSParticipants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. |
| Smoking Cessation and Health & Wellness | Active comparator | Behavioral: Smoking Cessation and Health & WellnessParticipants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAT-CSAlso: Smoking Cessation and Mood ManagementAll 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. | Behavioural | BAT-CS |
| Smoking Cessation and Health & WellnessAll 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. | Behavioural | Smoking Cessation and Health & Wellness |
Primary outcome
7-day point prevalence abstinence from smoking
Time frame: 12 Months
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
Depression Symptoms
Time frame: 12 Months
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
11 secondary outcomes
Continuous Abstinence From Smoking Since Hospital Discharge
Time frame: 12 Months
Time to Smoking Relapse
Time frame: 12 Months
Time to Smoking Lapse
Time frame: 12 Months
Depressed mood
Time frame: The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
Positive Affect
Time frame: 12 Months
Negative Affect
Time frame: 12 Months
Systolic and Diastolic Blood Pressure
Time frame: 12 Months
Blood Bio-markers
Time frame: 12 Months
Major adverse cardiac events (MACE) and all cause mortality
Time frame: 5 years
Health Related Quality of Life
Time frame: 12 Months
Treatment Acceptability
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 37173792Adkins-Hempel M, Japuntich SJ, Chrastek M, Dunsiger S, Breault CE, Ayenew W, Everson-Rose SA, Nijjar PS, Bock BC, Wu WC, Miedema MD, Carlson BM, Busch AM. Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial. Addict Sci Clin Pract. 2023 May 12;18(1):29. doi: 10.1186/s13722-023-00388-9.
- Derived from this study: PubMed 41995991Ajayi AA, Adkins-Hempel M, Breault C, Ayenew W, Everson-Rose SA, Japuntich SJ, Dunsiger SI, Busch AM. Racial Disparities in Biopsychosocial Predictors of Short-Term Smoking Cessation Following Acute Coronary Syndrome Hospitalization. J Racial Ethn Health Disparities. 2026 Apr 17. doi: 10.1007/s40615-026-02940-0. Online ahead of print.
- Protocol paperLink provided by the sponsor.
- Individual participant dataSharing planned: No. Completely de-identified data (i.e.,data that has been cleaned of all 18 types of HIPAA identifiers) will be available to other qualified researchers. Within 18 months of study completion, we will make datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely). The NIH will be notified of transmissions of the data to interested investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Busch, PhD principal investigator
Senior Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAT-CS and Smoking Cessation and Health & Wellness in people with Acute Coronary Syndrome and Tobacco Use, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence from smoking (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413423, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.