Role of Oxygen for Vascular Dysfunction | NCT02127333

Studies
Role of Oxygen for Vascular Dysfunction

NCT02127333

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Status

Completed

Last Update Posted

Dec 16, 2014Estimated

Enrollment

38Actual

Phase

Not provided

Conditions

Endothelial Dysfunction
FMD
IMT
Microcirculation
Oxygen Pressure
Carbon Dioxide Pressure
Oxygen Saturation
Forced Expiratory Volume After 1 Second

Interventions

Not provided

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

Dec 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

Jan 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Apr 29, 2014

First Submission Date that Met QC Criteria

Apr 29, 2014

First Posted Date

Apr 30, 2014Estimated

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

Dec 14, 2014

Last Update Posted Date

Dec 16, 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

Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for vascular function. For this purpose we measure capillary oxygen concentration and vascular.

Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood flow and laser doppler perfusion imaging.

We hypothesize that hypoxemia leads to impaired vascular function.

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

38Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Flow-mediated dilation of the brachial artery		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Forearm blood flow		Baseline
Laser doppler perfusion		Baseline
Intima-media thickness of the brachial artery

Other Outcomes

Measure	Description	Time Frame
Plasma nitrite concentration		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stable coronary artery disease
stable chronic obstructive pulmonary disease

Exclusion Criteria:

acute myocardial infarction within 30 days
acute exacerbated COPD within 30 days
acute infections
severe acute or chronic renal failure
severe heart failure
atrial fibrillation
severe cardiac arrhythmia
hypotension
active malignant disease
active rheumatic disease
pulmonary hypertension with vasoactive therapy

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

CAD patients with or without COPD; healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Pulmonary Disease and Vascular Medicine		Düsseldorf		40225	Germany

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
CAD patients with COPD
CAD patients without COPD
healthy volunteers