Pulmonary EmbolismNCT01318174
Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Embolism and Chronic Obstructive Pulmonary Disease, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Chronic Obstructive Pulmonary Disease
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or suspected COPD admitted with an exacerbation of unknown aetiology
Who may be able to join
- known or suspected COPD
- COPD-exacerbation
Who cannot join
- other causes of dyspnea
- unable to perform CT pulmonary angio (contrast allergy, pregnancy)
- already included in the study (each patient included only once)
- use of anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines.
- Keywords
- Pulmonary embolism, Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Embolism, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pulmonary embolism in exacerbations of COPD
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksander Talgøy Holten, Sykehuset Innlandet HF
- Investigators
- Aleksander T Holten, PhD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318174
- Sponsor's protocol ID
- LE-KE
- Status last verified
- Jul 2014
- First submitted
- 17 Mar 2011
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01318174
- Acronym / sponsor ID
- LE-KE
- Keywords
- Pulmonary embolism, Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Mar 2011 (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.
The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected COPD admitted with an exacerbation of unknown aetiology
Key inclusion criteria (2 listed)
- known or suspected COPD
- COPD-exacerbation
Key exclusion criteria (4 listed)
- other causes of dyspnea
- unable to perform CT pulmonary angio (contrast allergy, pregnancy)
- already included in the study (each patient included only once)
- use of anticoagulants
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
Prevalence of pulmonary embolism in exacerbations of COPD
Time frame: one year
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 8 Jul 2014.
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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.
Aleksander T Holten, PhD principal investigator
Sykehuset Innlandet HF
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 Pulmonary Embolism and Chronic Obstructive Pulmonary Disease, run by Sykehuset Innlandet HF at 1 site in Norway.
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 4 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 8 Jul 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 Norway. 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?
Prevalence of pulmonary embolism in exacerbations of COPD (time frame: one year). 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 8 Jul 2014.