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Integrated Treatment for Smoking Cessation After Acute Coronary Syndrome

N/A

Waitlist Available

Led By Andrew Busch, PhD

Research Sponsored by Hennepin Healthcare Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to consider quitting smoking at discharge

Has a telephone or is willing to use a study issued cell phone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will test whether a single, integrated treatment that targets both depressed mood and smoking is more effective than usual care in reducing post-acute coronary syndrome mortality.

Who is the study for?

This trial is for hospital inpatients aged 18-75 who had an acute coronary syndrome (ACS) event within the last month, smoke at least one cigarette daily before hospitalization, speak English, are considering quitting smoking after discharge, and can use a phone. It's not for those with severe mental illness or high risk of dying within six months.Check my eligibility

What is being tested?

The PACES study tests BAT-CS, an integrated treatment targeting both depression and smoking cessation post-ACS. The goal is to see if this combined approach can effectively reduce mortality by addressing mood issues that may hinder quitting smoking.See study design

What are the potential side effects?

While specific side effects aren't listed for Behavioral Activation Treatment (BAT), potential risks may include discomfort discussing personal issues during therapy sessions and emotional distress related to behavior changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am open to quitting smoking after leaving the hospital.

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I have access to a phone or am willing to use one provided by the study.

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I was hospitalized for acute coronary syndrome (ACS) within the last 30 days.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

7-day point prevalence abstinence from smoking

Depression Symptoms

Secondary outcome measures

Blood Bio-markers

Continuous Abstinence From Smoking Since Hospital Discharge

Depressed mood

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BAT-CSExperimental Treatment1 Intervention

Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.

Group II: Smoking Cessation and Health & WellnessActive Control1 Intervention

Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hennepin Healthcare Research InstituteLead Sponsor

90 Previous Clinical Trials

76,944 Total Patients Enrolled

6 Trials studying Acute Coronary Syndrome

7,435 Patients Enrolled for Acute Coronary Syndrome

Minneapolis Heart Institute FoundationOTHER

29 Previous Clinical Trials

15,232 Total Patients Enrolled

1 Trials studying Acute Coronary Syndrome

32 Patients Enrolled for Acute Coronary Syndrome

The Miriam HospitalOTHER

238 Previous Clinical Trials

37,242 Total Patients Enrolled

3 Trials studying Acute Coronary Syndrome

88 Patients Enrolled for Acute Coronary Syndrome

Media Library

BAT-CS Clinical Trial Eligibility Overview. Trial Name: NCT03413423 — N/A

Acute Coronary Syndrome Research Study Groups: Smoking Cessation and Health & Wellness, BAT-CS

Acute Coronary Syndrome Clinical Trial 2023: BAT-CS Highlights & Side Effects. Trial Name: NCT03413423 — N/A

BAT-CS 2023 Treatment Timeline for Medical Study. Trial Name: NCT03413423 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which population would be best suited to participate in this experiment?

"For this trial, 324 individuals aged 18 to 75 with a recent diagnosis of acute coronary syndrome are required. These participants must also possess the following attributes: fluency in English, smoking history of at least 1 cigarette per day prior to hospitalization, inpatient status, access to or willingness to use a study issued cell phone and agreement for consenting all trial procedures including potential quitting from smoking upon discharge."

Answered by AI

Is the enrollment process for this clinical research still open?

"Indeed, clinicaltrials.gov has verified that this trial is actively searching for volunteers to join their study. This experiment was initially posted on January 29th 2018 and the latest update occurred on August 2nd 2022."

Answered by AI

Is eligibility for this research endeavor limited to persons aged 60 and over?

"The age range of eligible patients for this study is between 18 years old and 75 years old."

Answered by AI

What is the projected enrolment size of this research endeavor?

"Affirmative. The details hosted on clinicaltrials.gov suggest that this experiment, which was first introduced to the public on 29th January 2018 is currently in need of enrolment. A total of 324 patients are required from 1 medical facility."

Answered by AI

What objectives does this experiment seek to achieve?

"This clinical trial will run for 12 months with the main objective of evaluating Depression Symptoms. Secondary objectives include testing Blood Bio-markers (HDL, LDL, High Sensitivity C-reactive protein and Fibrinogen), determining Resting Systolic and Diastolic Blood Pressure levels, as well as assessing Treatment Acceptability through a Client Satisfaction Questionnaire."

Answered by AI