Atrial FibrillationSAFE-PENCT03274401
Screening for Atrial Fibrillation in Pulmonary Embolism Study -SAFE-PE Study
A study testing Zenicor intermittent ECG device and 5 day ECG patch in people with Atrial Fibrillation and Pulmonary Embolism, run by Danderyd Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Pulmonary Embolism
- What is being tested?
- Zenicor intermittent ECG device and 5 day ECG patch
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 13 Sep 2017to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Atrial Fibrillation in Pulmonary Embolism Study - SAFE-PE Study
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.
Read the 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
- Being tested
- Zenicor intermittent ECG device, 5 day ECG patch
- Keywords
- Atrial fibrillation, Pulmonary embolism, Screening
- Medical subject headings
- Atrial Fibrillation, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenicor intermittent ECG deviceDevice
Also called Oral anticoagulant therapy prolonged (if AF detected)
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 patchDevice
Also called Oral anticoagulant therapy prolonged if AF detected
Selection of device for monitoring clinicians' choice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Zenicor intermittent ECG device; Device: 5 day ECG patch |
| Control Arm | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality in the screening arm compared to the control arm
Measured: 5 years after intervention
Secondary outcomes (1)
Mortality and thromboembolic events
Combined endpoint of mortality and thromboembolic events (stroke, transient ischemic attack, systemic embolism, deep vein thrombosis and pulmonary embolism) in the screening arm compared to the control arm
Measured: 5 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start13 Sep 2017
- Primary completion31 Dec 2020
- Study completion1 Apr 2022
Why it stopped: Due to Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with newly diagnosed pulmonary embolism will be randomized to screening for atrial fibrillation or standard of care
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Håkan Wallén, MD PhD, Study director, Karolinska Institutet - Danderyd HospitalEmma Svennberg, MD PhD, Principal investigator, Karolinska Institutet - Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274401
- Sponsor's protocol ID
- SAFE-PE
- Acronym
- SAFE-PE
- Status last verified
- Jul 2022
- First submitted
- 24 Aug 2017
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Atrial Fibrillation in Pulmonary Embolism Study - SAFE-PE Study
- ClinicalTrials.gov ID
- NCT03274401
- Acronym / sponsor ID
- SAFE-PE / SAFE-PE
- Conditions
- Atrial Fibrillation, Pulmonary Embolism
- Keywords
- Atrial fibrillation, Pulmonary embolism, Screening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid-19
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with newly diagnosed pulmonary embolism will be randomized to screening for atrial fibrillation or standard of care
| Arm | Type | Receives |
|---|---|---|
| Screening Arm | Active comparator | Device: Zenicor intermittent ECG device, Device: 5 day ECG patchScreening 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. |
| Control Arm | No intervention | –Standard of care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenicor intermittent ECG deviceAlso: Oral anticoagulant therapy prolonged (if AF detected)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 | Screening Arm |
| 5 day ECG patchAlso: Oral anticoagulant therapy prolonged if AF detectedSelection of device for monitoring clinicians' choice | Device | Screening Arm |
Primary outcome
Mortality
Time frame: 5 years after intervention
Mortality in the screening arm compared to the control arm
1 secondary outcome
Mortality and thromboembolic events
Time frame: 5 years after intervention
Results and safety
The study was stopped early (reason given: Due to Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håkan Wallén, MD PhD study director
Karolinska Institutet - Danderyd Hospital
Emma Svennberg, MD PhD principal investigator
Karolinska Institutet - Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenicor intermittent ECG device and 5 day ECG patch in people with Atrial Fibrillation and Pulmonary Embolism, run by Danderyd Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to Covid-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 5 years after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.