Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle

Atherosclerosis Clinical Trial

Official title:

Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795249
• Other study ID #: KurumeU-08061
• Status: Completed
• Phase: Phase 0
• First received: November 20, 2008
• Last updated: June 22, 2011
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: May 2010
• Source: Kurume University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Behavioral:
• smoking cessation
After baseline examination, the group is asked to quit smoking for 2 weeks.

Locations

Country	Name	City	State
Japan	Kurume University Hospital	Kurume	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of circulating EMP		2 weeks	No
Secondary	FMD		2 weeks	No