Back to resultsEffects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Early Phase 1
Locations
Japan
Study Type
Interventional
Intervention
smoking cessation
Sponsored by
About this trial
This is an interventional screening trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- healthy individuals who have no coronary risk factors
Exclusion Criteria:
- hypertension
- dyslipidemia
- chronic kidney disease
- liver dysfunction
- obesity (BMI>25.0)
- cerebrovascular disease
- other severe systemic diseases (cancer, inflammatory diseases, etc)
Sites / Locations
- Kurume University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
smoker
non-smoker
Arm Description
Individuals who have a habit of chronic smoking without any coronary risk factors
the age-matched healthy volunteers
Outcomes
Primary Outcome Measures
The number of circulating EMP
Secondary Outcome Measures
FMD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00795249
Brief Title
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Official Title
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kurume University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hypothesized that circulating EMP is a useful surrogate marker of early stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP, from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were repeated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
smoker
Arm Type
Experimental
Arm Description
Individuals who have a habit of chronic smoking without any coronary risk factors
Arm Title
non-smoker
Arm Type
No Intervention
Arm Description
the age-matched healthy volunteers
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation
Intervention Description
After baseline examination, the group is asked to quit smoking for 2 weeks.
Primary Outcome Measure Information:
Title
The number of circulating EMP
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
FMD
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy individuals who have no coronary risk factors
Exclusion Criteria:
hypertension
dyslipidemia
chronic kidney disease
liver dysfunction
obesity (BMI>25.0)
cerebrovascular disease
other severe systemic diseases (cancer, inflammatory diseases, etc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsutomu Imaizumi, MD, PhD
Organizational Affiliation
Kurume University
Official's Role
Study Chair
Facility Information:
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
We'll reach out to this number within 24 hrs