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Arterial Remodeling in Smokers (TCA)

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ClinicalTrials.gov Identifier: NCT01862146
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief 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).

Condition or disease Intervention/treatment
FMD IMT Smoking Procedure: smoke expose

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Response-to-injury in Patients Undergoing Transradial Coronary Angiography: Arterial Remodeling in Smokers
Study Start Date : April 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Group/Cohort Intervention/treatment
Current Smoker underwent TCA
subjects who smokes daily
Procedure: smoke expose
Former Smokers underwent TCA
subjects who do not smoke since 7 years



Primary Outcome Measures :
  1. IMT hyperplasia [ Time Frame: change in radials IMT after 6-14 month after a TCA ]
    IMT is measured by high resolution ultrasound in the radial arteries.


Secondary Outcome Measures :
  1. Endothelial function [ Time Frame: change in flow mediated dilatation after 10-14 months ]
    Flow mediated dilatation (FMD)


Other Outcome Measures:
  1. cell migration [ Time Frame: baseline ]
    measured by boyden chamber from blood plasma

  2. Regeneration [ Time Frame: baseline ]
    measured by scratch assay



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all subjects who underwent an TCA (trans radial catheterisation)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862146


Locations
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Germany
Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Investigators
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Principal Investigator: Christian Heiss, MD Division of Cardiology, Pulmonology and Vascular Medicine
Study Chair: Malte Kelm, MD Division of Cardiology, Pulmonology and Vascular Medicine

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01862146     History of Changes
Other Study ID Numbers: TCA INJURY
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
TCA
FMD
IMT
Smoking