Chronic Thromboembolic Pulmonary DiseaseNCT03729492
Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism
A study testing CTEPH/CTED work-up in people with Chronic Thromboembolic Pulmonary Disease, run by University of Aarhus.
Trial summary
Aim: To investigate if a symptom driven referral for chronic thrombosis in the lungs after acute pulmonary embolism is better than the current approach. Background: A number of patients with chronic thrombosis in the lungs after acute pulmonary embolism have dyspnea and reduced functional capacity without elevated… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Disease
- What is being tested?
- CTEPH/CTED work-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Nov 2022
- Phase
- Interventional
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute PE diagnosed by CT or V/Q-scan within the last year.
- Non-recovery or persistent PE related symptoms assessed by a MRC breathlessness score or WHO functional class.
- Age >= 18 and < 80
Who cannot join
- Contraindications or unable to perform 6 minutes walk distance (6MWD) and/or cardiopulmonary exercise test.
- Contraindications to CT pulmonary angiography.
- Congestive heart failure (LVEF <40%).
- COPD or restrictive lung disease, severe or worse (FEV1 <50% and >=1 exacerbation causing hospital admission per year (GOLD grade 3 and 4 class C and D)).
- Lactating or pregnant.
- Unable or unwilling to provide written informed consent.
- Paroxysmal or persistent atrial fibrillation.
- Other known cause of PE related symptoms.
Trial locations and contacts
No sites are listed yet.
About this study
Aim: To investigate if a symptom driven referral for chronic thrombosis in the lungs after acute pulmonary embolism is better than the current approach.
Background: A number of patients with chronic thrombosis in the lungs after acute pulmonary embolism have dyspnea and reduced functional capacity without elevated pulmonary arterial pressure at rest (CTED). However, current guidelines for follow-up after acute pulmonary embolism will miss all patients with CTED, as referral for further examination is based on elevated pulmonary arterial pressure on echocardiography. Thus, the prevalence of CTED is unknown. The hypothesis is, that a symptom-driven referral of patients with previous acute pulmonary embolism is more sensitive in diagnosing CTED than the current approach.
Methods and materials: Patients diagnosed with acute pulmonary embolism in Region Midt (approx. 350 per year) will be screened for non-recovery or persistent pulmonary embolism related symptoms during their 3-6 months follow up at their local outpatient clinic. If the patient has persistent symptoms they will be referred to a scintigraphy. If CTED is suspected from the scintigraphy, the patient will be referred for full CTED work-up. The investigators expect to screen 300 patients for persistent symptoms with an expected study time of 3 years.
- Conditions
- Chronic Thromboembolic Pulmonary Disease
- Being tested
- CTEPH/CTED work-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTEPH/CTED work-upDiagnostic test
Patients diagnosed with acute pulmonary embolism (PE) in Region Midt (approx. 350 per year) will be screened for non-recovery or persistent PE related symptoms during their 3-6 months follow up at their local outpatient clinic. If the patient has persistent symptoms they will be referred to a V/Q-scan. If a V/Q mismatch is present, the patient will be referred to a full work-up for CTEPH/CTED.
| Study group | Role | What they receive |
|---|---|---|
| CTEPH/CTED work-up | Other | Not described Receives: Diagnostic Test: CTEPH/CTED work-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CTED
Measured: 3 years
Secondary outcomes (1)
Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography.
Sensibility, specificity, positive predictive value and negative predictive value
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study startFeb 2019 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitalsenheden Vest
- Responsible party
- Sponsor
- Investigators
- Asger Andersen, MD, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729492
- Sponsor's protocol ID
- CTEPH
- Status last verified
- Oct 2018
- First submitted
- 1 Nov 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03729492
- Acronym / sponsor ID
- CTEPH
- Conditions
- Chronic Thromboembolic Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Hospitalsenheden Vest
- Study start
- Feb 2019 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 2 Nov 2018 (actual)
- 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.
Aim: To investigate if a symptom driven referral for chronic thrombosis in the lungs after acute pulmonary embolism is better than the current approach.
Background: A number of patients with chronic thrombosis in the lungs after acute pulmonary embolism have dyspnea and reduced functional capacity without elevated pulmonary arterial pressure at rest (CTED). However, current guidelines for follow-up after acute pulmonary embolism will miss all patients with CTED, as referral for further examination is based on elevated pulmonary arterial pressure on echocardiography. Thus, the prevalence of CTED is unknown. The hypothesis is, that a symptom-driven referral of patients with previous acute pulmonary embolism is more sensitive in diagnosing CTED than the current approach.
Methods and materials: Patients diagnosed with acute pulmonary embolism in Region Midt (approx. 350 per year) will be screened for non-recovery or persistent pulmonary embolism related symptoms during their 3-6 months follow up at their local outpatient clinic. If the patient has persistent symptoms they will be referred to a scintigraphy. If CTED is suspected from the scintigraphy, the patient will be referred for full CTED work-up. The investigators expect to screen 300 patients for persistent symptoms with an expected study time of 3 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTEPH/CTED work-up | Other | Diagnostic Test: CTEPH/CTED work-up |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute PE diagnosed by CT or V/Q-scan within the last year.
- Non-recovery or persistent PE related symptoms assessed by a MRC breathlessness score or WHO functional class.
- Age >= 18 and < 80
Key exclusion criteria (8 listed)
- Contraindications or unable to perform 6 minutes walk distance (6MWD) and/or cardiopulmonary exercise test.
- Contraindications to CT pulmonary angiography.
- Congestive heart failure (LVEF <40%).
- COPD or restrictive lung disease, severe or worse (FEV1 <50% and >=1 exacerbation causing hospital admission per year (GOLD grade 3 and 4 class C and D)).
- Lactating or pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTEPH/CTED work-upPatients diagnosed with acute pulmonary embolism (PE) in Region Midt (approx. 350 per year) will be screened for non-recovery or persistent PE related symptoms during their 3-6 months follow up at their local outpatient clinic. If the patient has persistent symptoms they will be referred to a V/Q-scan. If a V/Q mismatch is present, the patient will be referred to a full work-up for CTEPH/CTED. | Diagnostic test | CTEPH/CTED work-up |
Primary outcome
Prevalence of CTED
Time frame: 3 years
1 secondary outcome
Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Asger Andersen, MD, PhD study chair
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CTEPH/CTED work-up in people with Chronic Thromboembolic Pulmonary Disease, run by University of Aarhus.
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 3 inclusion and 8 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Mona S Hansen, MD (+45 42552335, monahs@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CTED (time frame: 3 years). 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 2 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.