CTEPHNCT01672203
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism
An observational study of CTEPH, run by University of Cologne at 1 site in Germany.
Trial summary
Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for development of CTEPH. It is not known, whether the location of pulmonary embolism (central vs. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- CTEPH
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Nov 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were hospitalized for acute pulmonary embolism at the University Hospital of Cologne.
Who may be able to join
- acute pulmonary embolism for at least 12 months
Who cannot join
- known pulmonary hypertension other than CTEPH
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heart Center of the University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
Fikret Er, MD, +49-221-47832396, fikret.er@uk-koeln.de
Fikret Er, MD
About this study
Official title: Incidence of CTEPH in Dependence of Thrombus Location in Patients With Acute Pulmonary Embolism and Index Fibrinolysis
Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for development of CTEPH. It is not known, whether the location of pulmonary embolism (central vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been performed to assess the CTEPH incidence in different populations: in patients with central vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.
Read the detailed description
The embolus localization during index pulmonary embolism might be of potential relevance for CTEPH development.
In the present study patients with confirmed pulmonary embolism for at least 12 months will be screened for CTEPH. The incidence of CTEPH will be correlated to thrombus location (central vs. peripheral) and the index use of fibrinolysis.
- Conditions
- CTEPH
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 |
|---|---|---|
| PE peripheral with fibrinolysis | Patients with peripheral PE who received fibrinolysis therapy | |
| PE peripheral, no fibrinolysis | Patients with peripheral PE who did not receive fibrinolysis | |
| PE central with fibrinolysis | Patients with central PE who received fibrinolysis therapy | |
| PE central, no fibrinolysis | Patients with central PE who did not receive fibrinolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTEPH
Incidence of CTEPH
Measured: participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startJan 2009
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTEPHStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fikret Er, University of Cologne
- Investigators
- Fikret Er, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672203
- Sponsor's protocol ID
- UKK-PostLE
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2012
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of CTEPH in Dependence of Thrombus Location in Patients With Acute Pulmonary Embolism and Index Fibrinolysis
- ClinicalTrials.gov ID
- NCT01672203
- Acronym / sponsor ID
- UKK-PostLE
- Conditions
- CTEPH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 24 Aug 2012 (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.
Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for development of CTEPH. It is not known, whether the location of pulmonary embolism (central vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been performed to assess the CTEPH incidence in different populations: in patients with central vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.
Detailed description
The embolus localization during index pulmonary embolism might be of potential relevance for CTEPH development.
In the present study patients with confirmed pulmonary embolism for at least 12 months will be screened for CTEPH. The incidence of CTEPH will be correlated to thrombus location (central vs. peripheral) and the index use of fibrinolysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PE peripheral with fibrinolysis | – | –Patients with peripheral PE who received fibrinolysis therapy |
| PE peripheral, no fibrinolysis | – | –Patients with peripheral PE who did not receive fibrinolysis |
| PE central with fibrinolysis | – | –Patients with central PE who received fibrinolysis therapy |
| PE central, no fibrinolysis | – | –Patients with central PE who did not receive fibrinolysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were hospitalized for acute pulmonary embolism at the University Hospital of Cologne.
Key inclusion criteria (1 listed)
- acute pulmonary embolism for at least 12 months
Key exclusion criteria (1 listed)
- known pulmonary hypertension other than CTEPH
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
CTEPH
Time frame: participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated
Incidence of CTEPH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
Related trials for CTEPH
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Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
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The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
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A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
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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.
Fikret Er, MD principal investigator
University of Cologne
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 CTEPH, run by University of Cologne 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fikret Er, MD (+49-221-478-32396, fikret.er@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTEPH (time frame: participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated). 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 24 Aug 2012.