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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
Sponsor:
Collaborator:
Hospitalsenheden Vest
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Disease Diagnostic Test: CTEPH/CTED work-up Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
CTEPH/CTED work-up 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.


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of CTED [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography. [ Time Frame: 3 years ]
    Sensibility, specificity, positive predictive value and negative predictive value


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mona S Hansen, MD +45 42552335 monahs@rm.dk
Contact: Asger Andersen, MD, PhD +45 26363226 asger.andersen@clin.au.dk

Sponsors and Collaborators
University of Aarhus
Hospitalsenheden Vest
Investigators
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Study Chair: Asger Andersen, MD, PhD Aarhus University Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03729492    
Other Study ID Numbers: CTEPH
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Embolism
Hypertension
Embolism
Thromboembolism
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis