Arterial Remodeling in Smokers | NCT01862146

Studies
Arterial Remodeling in Smokers

NCT01862146

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Status

Completed

Last Update Posted

Jun 4, 2014Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

FMD
IMT
Smoking

Interventions

smoke expose

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 22, 2013

First Submission Date that Met QC Criteria

May 23, 2013

First Posted Date

May 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2014

Last Update Posted Date

Jun 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, DuesseldorfSponsor-Investigator

Lead Sponsor

Klinik für Kardiologie, Pneumologie und AngiologieOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Current Smoker underwent TCA		subjects who smokes daily	Procedure: smoke expose
Former Smokers underwent TCA		subjects who do not smoke since 7 years

Interventions

Name	Type	Description	Arm Group Labels	Other Names
smoke expose	Procedure		Current Smoker underwent TCA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Endothelial function	Flow mediated dilatation (FMD)	change in flow mediated dilatation after 10-14 months

Other Outcomes

Measure	Description	Time Frame
cell migration	measured by boyden chamber from blood plasma	baseline
Regeneration	measured by scratch assay	baseline

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

all subjects who underwent an TCA (trans radial catheterisation)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Heiss, MD	Division of Cardiology, Pulmonology and Vascular Medicine	Principal Investigator
Malte Kelm, MD	Division of Cardiology, Pulmonology and Vascular Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,		Düsseldorf	North Rhine-Westphalia	40225	Germany