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

NCT03274401 | Terminated

• 1 other identifier: SAFE-PE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Pulmonary Embolism

Keywords

Atrial fibrillation; Pulmonary embolism; Screening

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality in the screening arm compared to the control arm

  5 years after intervention

Secondary Outcomes (1)

• Mortality and thromboembolic events

  5 years after intervention

Other Outcomes (8)

• Quality of life using RAND-36

  1 year after inclusion

• Quality of life using EHRA symptom scale

  1 year after inclusion

• Assessment of clinical risk factors for atrial fibrillation in patients with pulmonary embolism

  1 year after inclusion

Study Arms (2)

Screening Arm

ACTIVE COMPARATOR

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.

Device: Zenicor intermittent ECG device; Device: 5 day ECG patch

Control Arm

NO INTERVENTION

Standard of care

Interventions

Zenicor intermittent ECG device 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

Also known as: Oral anticoagulant therapy prolonged (if AF detected)

Screening Arm

5 day ECG patch DEVICE

Selection of device for monitoring clinicians' choice

Also known as: Oral anticoagulant therapy prolonged if AF detected

Screening Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Danderyd Hospital

Stockholm, 182 88, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Håkan Wallén, MD PhD

  Karolinska Institutet - Danderyd Hospital

  STUDY DIRECTOR

• Emma Svennberg, MD PhD

  Karolinska Institutet - Danderyd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with newly diagnosed pulmonary embolism will be randomized to screening for atrial fibrillation or standard of care

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 7, 2017
• Study Start: September 13, 2017
• Primary Completion: December 31, 2020
• Study Completion: April 1, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)