Role of Oxygen for Vascular Dysfunction

NCT02127333 | Completed

• 1 other identifier: COPD_pO2
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

chronic obstructive pulmonary disease; Coronary artery disease; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilation of the brachial artery

  Baseline

Secondary Outcomes (5)

• Forearm blood flow

  Baseline

• Laser doppler perfusion

  Baseline

• Intima-media thickness of the brachial artery

  Baseline

• Fractional diameter change of the brachial artery

  Baseline

• Endothelium-independent vasodilation of the brachial artery

  Baseline

Other Outcomes (1)

• Plasma nitrite concentration

  Baseline

Study Arms (3)

CAD patients with COPD

CAD patients without COPD

healthy volunteers

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CAD patients with or without COPD; healthy volunteers

You may qualify if:

• stable coronary artery disease
• stable chronic obstructive pulmonary disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: April 30, 2014
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

DE (1)