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

Status

Completed

Conditions

Intervention / Treatment

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

  • Germany
    • NRW
      • Duesseldorf, NRW, Germany, 40225
        • Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

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
Procedure: smoke expose
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.

Sponsor

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 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

Terms related to this study

Keywords

Other Study ID Numbers

  • TCA INJURY

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.

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