Role of Oxygen for Vascular Dysfunction

December 14, 2014 updated by: Klinik für Kardiologie, Pneumologie und Angiologie

Role of Acute and Chronic Hypoxemia for Vascular Function

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

CAD patients with or without COPD; healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
healthy volunteers
CAD patients with COPD
CAD patients without COPD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Forearm blood flow
Time Frame: Baseline
Baseline
Laser doppler perfusion
Time Frame: Baseline
Baseline
Intima-media thickness of the brachial artery
Time Frame: Baseline
Baseline
Fractional diameter change of the brachial artery
Time Frame: Baseline
Baseline
Endothelium-independent vasodilation of the brachial artery
Time Frame: Baseline
Baseline

Other Outcome Measures

Outcome Measure
Time Frame
Plasma nitrite concentration
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 14, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COPD_pO2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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