NCT01862146

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

May 22, 2013

Last Update Submit

June 3, 2014

Conditions

FMDIMTSmoking

Keywords

TCAFMDIMTSmoking

Outcome Measures

Primary Outcomes (1)

  • IMT hyperplasia

    IMT is measured by high resolution ultrasound in the radial arteries.

    change in radials IMT after 6-14 month after a TCA

Secondary Outcomes (1)

  • Endothelial function

    change in flow mediated dilatation after 10-14 months

Other Outcomes (2)

  • cell migration

    baseline

  • Regeneration

    baseline

Study Arms (2)

Current Smoker underwent TCA

subjects who smokes daily

Procedure: smoke expose

Former Smokers underwent TCA

subjects who do not smoke since 7 years

Interventions

smoke exposePROCEDURE
Current Smoker underwent TCA

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all subjects who underwent an TCA (trans radial catheterisation)

You may qualify if:

  • all subjects underwent a TCA

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christian Heiss, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

  • Malte Kelm, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 24, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations

DE(1)