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NCT02127333 Clinical Trial

Role of Oxygen for Vascular Dysfunction

Endothelial Dysfunction Clinical Trial

Official title:
Role of Acute and Chronic Hypoxemia for Vascular Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02127333
Other study ID # COPD_pO2
Secondary ID
Status Completed
Phase N/A
First received April 29, 2014
Last updated December 14, 2014
Start date January 2011
Est. completion date September 2013

Study information
Verified date December 2014
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Division of Cardiology, Pulmonary Disease and Vascular Medicine Düsseldorf

Sponsors (1)
Lead Sponsor Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other Plasma nitrite concentration Baseline No
Primary Flow-mediated dilation of the brachial artery Baseline No
Secondary Forearm blood flow Baseline No
Secondary Laser doppler perfusion Baseline No
Secondary Intima-media thickness of the brachial artery Baseline No
Secondary Fractional diameter change of the brachial artery Baseline No
Secondary Endothelium-independent vasodilation of the brachial artery Baseline No
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