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

NCT ID: NCT03729492

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2022-11-30

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.

Conditions

Chronic Thromboembolic Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CTEPH/CTED work-up

Group Type: OTHER

CTEPH/CTED work-up

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospitalsenheden Vest

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asger Andersen, MD, PhD

Role: STUDY_CHAIR

Aarhus University Hospital

Central Contacts

Mona S Hansen, MD

Role: CONTACT

monahs@rm.dk

+45 42552335

Asger Andersen, MD, PhD

Role: CONTACT

asger.andersen@clin.au.dk

+45 26363226

Other Identifiers

CTEPH

Identifier Type: -

Identifier Source: org_study_id