NCT03274401

Screening for Atrial Fibrillation in Pulmonary Embolism Study -SAFE-PE Study

Screening for Atrial Fibrillation in Pulmonary Embolism Study - SAFE-PE Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Danderyd Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	Zenicor intermittent ECG device	At least two weeks of screening twice daily for atrial fibrillation using intermittent ECG recordings, and prolonged use of OAC-therapy if atrial fibrillation is detected
DEVICE	5 day ECG patch	Selection of device for monitoring clinicians' choice

Timeline

• Start date: 2017-09-13
• Primary completion: 2020-12-31
• Completion: 2022-04-01
• First posted: 2017-09-07
• Last updated: 2022-07-28

Locations

1 site across 1 country: Sweden