Endothelial DysfunctionNCT02127333
Role of Oxygen for Vascular Dysfunction
An observational study of Endothelial Dysfunction and FMD, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, FMD, IMT
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: CAD patients with or without COPD; healthy volunteers
Who may be able to join
- stable coronary artery disease
- stable chronic obstructive pulmonary disease
Who cannot join
- 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
Show all 11Show fewer
- severe cardiac arrhythmia
- hypotension
- active malignant disease
- active rheumatic disease
- pulmonary hypertension with vasoactive therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: 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.
- Conditions
- Endothelial Dysfunction, FMD, IMT, Microcirculation, Oxygen Pressure, Carbon Dioxide Pressure
- Keywords
- chronic obstructive pulmonary disease, Coronary artery disease, Endothelial function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAD patients with COPD | Not described | |
| CAD patients without COPD | Not described | |
| healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation of the brachial artery
Measured: Baseline
Secondary outcomes (5)
Forearm blood flow
Measured: Baseline
Laser doppler perfusion
Measured: Baseline
Intima-media thickness of the brachial artery
Measured: Baseline
Fractional diameter change of the brachial artery
Measured: Baseline
Endothelium-independent vasodilation of the brachial artery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJan 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular MedicineMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicineine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127333
- Sponsor's protocol ID
- COPD_pO2
- Status last verified
- Dec 2014
- First submitted
- 29 Apr 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Acute and Chronic Hypoxemia for Vascular Function
- ClinicalTrials.gov ID
- NCT02127333
- Acronym / sponsor ID
- COPD_pO2
- Conditions
- Endothelial Dysfunction, FMD, IMT, Microcirculation, Oxygen Pressure, Carbon Dioxide Pressure
- Keywords
- chronic obstructive pulmonary disease, Coronary artery disease, Endothelial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAD patients with COPD | – | – |
| CAD patients without COPD | – | – |
| healthy volunteers | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CAD patients with or without COPD; healthy volunteers
Key inclusion criteria (2 listed)
- stable coronary artery disease
- stable chronic obstructive pulmonary disease
Key exclusion criteria (11 listed)
- acute myocardial infarction within 30 days
- acute exacerbated COPD within 30 days
- acute infections
- severe acute or chronic renal failure
- severe heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flow-mediated dilation of the brachial artery
Time frame: Baseline
5 secondary outcomes
Forearm blood flow
Time frame: Baseline
Laser doppler perfusion
Time frame: Baseline
Intima-media thickness of the brachial artery
Time frame: Baseline
Fractional diameter change of the brachial artery
Time frame: Baseline
Endothelium-independent vasodilation of the brachial artery
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Related InfoLink provided by the sponsor.
Related trials for Endothelial Dysfunction
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Heiss, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicineine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction and FMD, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation of the brachial artery (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.