Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism
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|ClinicalTrials.gov Identifier: NCT03729492|
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Thromboembolic Pulmonary Disease||Diagnostic Test: CTEPH/CTED work-up||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Diagnostic Test: CTEPH/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.
- Prevalence of CTED [ Time Frame: 3 years ]
- Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography. [ Time Frame: 3 years ]Sensibility, specificity, positive predictive value and negative predictive value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729492
|Contact: Mona S Hansen, MD||+45 firstname.lastname@example.org|
|Contact: Asger Andersen, MD, PhD||+45 email@example.com|
|Study Chair:||Asger Andersen, MD, PhD||Aarhus University Hospital|