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
About this trial
This is an interventional diagnostic trial for Chronic Thromboembolic Pulmonary Disease
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.
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
NCT ID
NCT03729492
First Posted
November 1, 2018
Last Updated
November 1, 2018
Sponsor
University of Aarhus
Collaborators
Hospitalsenheden Vest
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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