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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Thromboembolic Pulmonary Disease
• Intervention / Treatment: Diagnostic test: CTEPH/CTED work-up

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of CTED	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of dual energy CT perfusion and pulmonary angiography.	Sensibility, specificity, positive predictive value and negative predictive value	3 years

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Hospitalsenheden Vest
• Investigators: Study Chair: Asger Andersen, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Hypertension; Embolism; Thromboembolism; Hypertension, Pulmonary; Pulmonary Embolism
• Other Study ID Numbers: CTEPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No