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Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism

Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03729492
Enrollment
100
Registered
2018-11-02
Start date
2019-02-28
Completion date
2022-11-30
Last updated
2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Disease

Brief 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 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.

Interventions

DIAGNOSTIC_TESTCTEPH/CTED work-up

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.

Sponsors

Hospitalsenheden Vest
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Prevalence of CTED3 years

Secondary

MeasureTime frameDescription
Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography.3 yearsSensibility, specificity, positive predictive value and negative predictive value

Contacts

Primary ContactMona S Hansen, MD
monahs@rm.dk+45 42552335
Backup ContactAsger Andersen, MD, PhD
asger.andersen@clin.au.dk+45 26363226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026