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Role of Oxygen for Vascular Dysfunction

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie (Other)
Overall Status
Completed
CT.gov ID
NCT02127333
Collaborator
(none)
38
Enrollment
1
Location
32
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    38 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Role of Acute and Chronic Hypoxemia for Vascular Function
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2013
    Actual Study Completion Date :
    Sep 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    CAD patients with COPD
    CAD patients without COPD
    healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    1. Flow-mediated dilation of the brachial artery [Baseline]

    Secondary Outcome Measures

    1. Forearm blood flow [Baseline]

    2. Laser doppler perfusion [Baseline]

    3. Intima-media thickness of the brachial artery [Baseline]

    4. Fractional diameter change of the brachial artery [Baseline]

    5. Endothelium-independent vasodilation of the brachial artery [Baseline]

    Other Outcome Measures

    1. Plasma nitrite concentration [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Pulmonary Disease and Vascular Medicine Düsseldorf Germany 40225

    Sponsors and Collaborators

    • Klinik für Kardiologie, Pneumologie und Angiologie

    Investigators

    • Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine
    • Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicineine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT02127333
    Other Study ID Numbers:
    • COPD_pO2
    First Posted:
    Apr 30, 2014
    Last Update Posted:
    Dec 16, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
    chronic obstructive pulmonary disease
    Coronary artery disease
    Endothelial function

    Study Results

    No Results Posted as of Dec 16, 2014