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NCT01862146 Clinical Trial

Arterial Remodeling in Smokers

Smoking Clinical Trial

— TCA  

Official title:
Response-to-injury in Patients Undergoing Transradial Coronary Angiography: Arterial Remodeling in Smokers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01862146
Other study ID # TCA INJURY
Secondary ID
Status Completed
Phase N/A
First received May 22, 2013
Last updated June 3, 2014
Start date April 2013
Est. completion date June 2014

Study information
Verified date June 2014
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Cigarette smoking is the most important modifiable cardiovascular risk factor leading to endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the study was to investigate the effect of smoking on vascular response to transradial coronary angiography (TCA).

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- all subjects underwent a TCA

Exclusion Criteria:

- acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) CRP > 1 mg/dl malignant disease

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• smoke expose

Locations
Country Name City State
Germany Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf, Duesseldorf NRW

Sponsors (1)
Lead Sponsor Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other cell migration measured by boyden chamber from blood plasma baseline No
Other Regeneration measured by scratch assay baseline No
Primary IMT hyperplasia IMT is measured by high resolution ultrasound in the radial arteries. change in radials IMT after 6-14 month after a TCA No
Secondary Endothelial function Flow mediated dilatation (FMD) change in flow mediated dilatation after 10-14 months No
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