TCA: Arterial Remodeling in Smokers
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie (Other)
Overall Status
Completed
CT.gov ID
NCT01862146
Collaborator
(none)
50
1
14
3.6
Study Details
Study Description
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).
Study Design
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
:
Apr 1, 2013
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- IMT hyperplasia [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
- Endothelial function [change in flow mediated dilatation after 10-14 months]
Flow mediated dilatation (FMD)
Other Outcome Measures
- cell migration [baseline]
measured by boyden chamber from blood plasma
- Regeneration [baseline]
measured by scratch assay
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf, | Duesseldorf | NRW | Germany | 40225 |
Sponsors and Collaborators
- Klinik für Kardiologie, Pneumologie und Angiologie
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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Klinik für Kardiologie, Pneumologie und Angiologie,
Division of Cardiology, Pulmonary Diseases, Vascular Medicine,
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01862146
Other Study ID Numbers:
- TCA INJURY
First Posted:
May 24, 2013
Last Update Posted:
Jun 4, 2014
Last Verified:
Jun 1, 2014