ROSCAP: Reduction of Smoking in Cardiac Patients Study | NCT00301626

Studies
ROSCAP: Reduction of Smoking in Cardiac Patients Study

NCT00301626

Sponsor

National Institutes of Health (NIH)

Status

Completed

Last Update Posted

Oct 24, 2008Estimated

Enrollment

180

Phase

Not Applicable

Conditions

Nicotine Dependence
Tobacco Dependence
Cardiac Disease

Interventions

smoking reduction intervention (including NRT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2000

Primary Completion Date

Not provided

Completion Date

Jan 2005

First Submitted Date

Mar 10, 2006

First Submission Date that Met QC Criteria

Mar 10, 2006

First Posted Date

Mar 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2008

Last Update Posted Date

Oct 24, 2008Estimated

Description Module

Brief Summary

Background. The ROSCAP Study was a randomized controlled trial in heart disease patients to test the effect of a smoking reduction intervention on cigarettes per day (cpd) and biochemical and clinical indicators of tobacco exposure. .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180

Name	Type	Description	Arm Group Labels	Other Names
smoking reduction intervention (including NRT)	Behavioral

Measure	Description	Time Frame
Smoking reduction

Measure	Description	Time Frame
Smoking cessation, biomarker measures

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

smoked at least 15 cigarettes per day and had one of 11 cardiovascular disorders: history of myocardial infarction, coronary artery bypass surgery, angioplasty, stent placement, thrombolytic therapy, angina, arrhythmia, a history of cardiac arrest, greater than 50% coronary artery stenosis by angiography, ischemia on exercise tolerance testing or congestive heart failure, required to confirm that they were unwilling or uninterested in setting a stop smoking date in the next 30 days.

Exclusion Criteria:

1) unstable angina within the past 2 weeks, 2) unstable psychiatric or substance use disorders or 3) contraindications to nicotine replacement therapy (including pregnancy or intention to become pregnant)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Joseph, MD, MPH	Minneapolis VAMC & University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minneapolis VAMC (111-0)		Minneapolis	Minnesota	55417	United States

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder
D006331	Heart Diseases
D000074264	Smoking Reduction

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided