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

NCT ID: NCT03274401

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2022-04-01

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.

Conditions

Atrial Fibrillation; Pulmonary Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening Arm

Screening for atrial fibrillation using a hand-held ECG device (Zenicor intermittent ECG) at least twice daily for two weeks. In patients where AF is detected prolonged OAC therapy will be administered.

Group Type: ACTIVE_COMPARATOR

Zenicor intermittent ECG device

Intervention Type: 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

5 day ECG patch

Intervention Type: DEVICE

Selection of device for monitoring clinicians' choice

Control Arm

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

5 day ECG patch

Selection of device for monitoring clinicians' choice

Intervention Type: DEVICE

Other Intervention Names

Oral anticoagulant therapy prolonged (if AF detected); Oral anticoagulant therapy prolonged if AF detected

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Håkan Wallén, MD PhD

Role: STUDY_DIRECTOR

Karolinska Institutet - Danderyd Hospital

Emma Svennberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet - Danderyd Hospital

Locations

Danderyd Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

SAFE-PE

Identifier Type: -

Identifier Source: org_study_id