Arterial Remodeling in Smokers (TCA)
June 3, 2014 updated by: Klinik für Kardiologie, Pneumologie und Angiologie
Response-to-injury in Patients Undergoing Transradial Coronary Angiography: Arterial Remodeling in Smokers
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).
Study Overview
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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NRW
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Duesseldorf, NRW, Germany, 40225
- Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all subjects who underwent an TCA (trans radial catheterisation)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Current Smoker underwent TCA
subjects who smokes daily
|
|
|
Former Smokers underwent TCA
subjects who do not smoke since 7 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
change in radials IMT after 6-14 month after a TCA
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endothelial function
Time Frame: change in flow mediated dilatation after 10-14 months
|
Flow mediated dilatation (FMD)
|
change in flow mediated dilatation after 10-14 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cell migration
Time Frame: baseline
|
measured by boyden chamber from blood plasma
|
baseline
|
|
Regeneration
Time Frame: baseline
|
measured by scratch assay
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine
- Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonology and Vascular Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 22, 2013
First Submitted That Met QC Criteria
May 23, 2013
First Posted (Estimate)
May 24, 2013
Study Record Updates
Last Update Posted (Estimate)
June 4, 2014
Last Update Submitted That Met QC Criteria
June 3, 2014
Last Verified
June 1, 2014
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.