Clinical trial NCT03274401: Screening for Atrial Fibrillation in Pulmonary Embolism Study -SAFE-PE Study
Official title: Screening for Atrial Fibrillation in Pulmonary Embolism Study - SAFE-PE Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Pulmonary Embolism
Keywords: Atrial fibrillation
Pulmonary embolism
Screening
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2017-09-07
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with newly diagnosed pulmonary embolism will be randomized to screening for atrial fibrillation or standard of care
Primary purpose: SCREENING

Brief summary: Patients with newly diagnosed pulmonary embolism and high thromboembolic risk will be randomized to screening for atrial fibrillation or standard of care using intermittent ECG registration for at least two weeks.

Detailed description: Patients included in the study might be referred for an ultrasound of deep vein thrombosis unless this has already been performed. Blood will be drawn in a subset of patients to assess cardiac biomarkers, and stored in a biobank for further analysis of thrombotic biomarkers. If a computed tomography (CT) angiogram was used as diagnostic method for pulmonary embolism a radiologic review will be performed to assess presence of right atrium thrombus, with the reviewer will be blinded to the presence of atrial fibrillation (AF). In addition, an echocardiogram of the heart will be performed.

Many patients with pulmonary embolism have prolonged symptoms of dyspnoea, and palpitations. These symptoms are also described in patients with atrial fibrillation. All participants will be asked to fill out a standardized quality of life (RAND-36)-, and a symptoms questionnaire (modified European Heart Rhythm association symptom scale). Upon inclusion all patients will be reviewed for factors predisposing to PE such as recent surgery, or illness requiring immobilisation within the past three months prior to index event.

After inclusion patients will be randomised to screening for atrial fibrillation or standard of care. Participants who get randomised into the screening arm will be screened for AF using a validated, handheld ECG device at least twice daily for two weeks. Participants who get AF diagnosed during the study will be referred for appropriate cardiology follow-up and the anticoagulant therapy will be changed from a fixed time to continued (subject to yearly reviews). Patients will then be followed for five years using the Swedish death registry, and the Swedish national patient registry, in combination with the national prescription registry for the outcomes.

Eligibility criteria: Inclusion Criteria:

* Recent pulmonary embolism (within three months)

Fulfilling Chads-Vasc criteria for life-long oral anticoagulant therapy (2 points for men, and 3 points for women), or age \> 65 years

Exclusion Criteria:

* Known diagnosis of atrial fibrillation Contra-indication to oral anticoagulant therapy Provoked pulmonary embolism in sub-segmental artery only Active cancer therapy (on-going therapy, recent surgery or life-expectancy below 1 year)

Primary outcomes:
measure: Mortality
timeFrame: 5 years after intervention
Secondary outcomes:
measure: Mortality and thromboembolic events
timeFrame: 5 years after intervention
Other outcomes:
measure: Quality of life using RAND-36
timeFrame: 1 year after inclusion
measure: Quality of life using EHRA symptom scale
timeFrame: 1 year after inclusion
measure: Assessment of clinical risk factors for atrial fibrillation in patients with pulmonary embolism
timeFrame: 1 year after inclusion
measure: Biomarkers as a prediction of diagnosis in pulmonary embolism
timeFrame: 5 years after inclusion
measure: The association between biomarkers and newly detected AF in patients with pulmonary embolism
timeFrame: 1 years after inclusion
measure: Echocardiographic measures and their association with outcome in patients with PE
timeFrame: 5 years after inclusion
measure: Echocardiographic parameters and their association with newly detected AF in patients with PE
timeFrame: 1 years after inclusion
measure: Presence of right atrial thrombus on DT angiography in PE
timeFrame: 5 years after inclusion
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Karolinska Institutet - Danderyd Hospital
name: Håkan Wallén, MD PhD
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet - Danderyd Hospital
name: Emma Svennberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: