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

Primary Purpose

Chronic Thromboembolic Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CTEPH/CTED work-up
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Thromboembolic Pulmonary Disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    CTEPH/CTED work-up

    Arm Description

    Outcomes

    Primary Outcome Measures

    Prevalence of CTED

    Secondary Outcome Measures

    Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography.
    Sensibility, specificity, positive predictive value and negative predictive value

    Full Information

    First Posted
    November 1, 2018
    Last Updated
    November 1, 2018
    Sponsor
    University of Aarhus
    Collaborators
    Hospitalsenheden Vest
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03729492
    Brief Title
    Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism
    Official Title
    Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Hospitalsenheden Vest

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Thromboembolic Pulmonary Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CTEPH/CTED work-up
    Arm Type
    Other
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    CTEPH/CTED work-up
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Prevalence of CTED
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography.
    Description
    Sensibility, specificity, positive predictive value and negative predictive value
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona S Hansen, MD
    Phone
    +45 42552335
    Email
    monahs@rm.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asger Andersen, MD, PhD
    Phone
    +45 26363226
    Email
    asger.andersen@clin.au.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Asger Andersen, MD, PhD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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