Cerebrovascular StrokePROACTIANCT02725944
Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and TIA
An observational study of Cerebrovascular Stroke and Atrial Fibrillation, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
PROACTIA is a prospective, event-driven observational study. It aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in patients after acute cryptogenic stroke and transient ischemic attack (TIA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Stroke, Atrial Fibrillation
- What is being tested?
- Implantation of ICRM
- Type of treatment
- Medical device
- How many people
- 251 participants
- Where
- 1 siteNorway
- Study dates
- 15 May 2016to 18 Jun 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 250 participants of both sexes included at Akershus University Hospital, Norway, within two weeks after diagnosed with cryptogenic stroke and/or TIA.
Who may be able to join
- Patients diagnosed with cryptogenic stroke and/or TIA, in accordance to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification.
Who cannot join
- Patients with known or newly detected AF on initial examination including 24 h Holter ECG.
- Patients on oral anticoagulants (OAC) for non-AF indications.
- Patients with strong contraindications for OAC, even if the presence of underlying AF is detected.
- Patients with atrial- or ventricular thrombi, or atheromas of the aortic arch greater than 4 mm, detected by transesophageal echocardiography.
- Patients unable to sign the informed consent or with a life expectancy due to comorbidities of less than two years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and Transient Ischemic Attack
PROACTIA is a prospective, event-driven observational study. It aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in patients after acute cryptogenic stroke and transient ischemic attack (TIA).
Read the detailed description
It will be enrolled 250 participants of both sexes within two weeks after diagnosed cryptogenic stroke and/or TIA at Akershus University Hospital, Oslo area, Norway.
Evaluation of participants' comorbidity with CHADS2-VASc score, ECG, Holter ECG, echocardiography, detection of biochemical cardiac markers and screening for obstructive sleep apnea syndrome will be performed. All participants will be monitored with a continuous cardiac rhythm during one year by implantation of implantable cardiac rhythm monitors (ICRM). All patients without high bleeding risk will get prescribed oral anticoagulants (OAC) after detection of PAF.
A biobank will be established in order to store the sampled biological material.
- Conditions
- Cerebrovascular Stroke, Atrial Fibrillation
- Being tested
- Implantation of ICRM
- Keywords
- Cryptogenic stroke, Occult paroxysmal atrial fibrillation
- Medical subject headings
- Stroke, Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of ICRMDevice
All patients will be implanted with ICRM in order to detect an occult PAF.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cryptogenic stroke and TIA | Implantation of ICRM in all participants. Receives: Device: Implantation of ICRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of paroxysmal atrial fibrillation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start15 May 2016
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loreta Skrebelyte-Strøm, MD, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725944
- Sponsor's protocol ID
- 2014/1260 D (REK)
- Acronym
- PROACTIA
- Status last verified
- Sep 2018
- First submitted
- 21 Mar 2016
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Skrebelyte-Strom L, Saberniak J, Bjorkan Orstad E, Mykland Hilde JE, Ronning OM, Steine K. Left atrial appendage function by strain and structure is associated with thromboembolic risk in patients with cryptogenic stroke and TIA. Open Heart. 2025 May 27;12(1):e003287. doi: 10.1136/openhrt-2025-003287.
PubMed 40436433Skrebelyte-Strom L, Ronning OM, Dahl FA, Steine K, Kjekshus H. Prediction of occult atrial fibrillation in patients after cryptogenic stroke and transient ischaemic attack: PROACTIA. Europace. 2022 Dec 9;24(12):1881-1888. doi: 10.1093/europace/euac092.
PubMed 35819199
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT02725944
- Acronym / sponsor ID
- PROACTIA / 2014/1260 D (REK)
- Conditions
- Cerebrovascular Stroke, Atrial Fibrillation
- Keywords
- Cryptogenic stroke, Occult paroxysmal atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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.
PROACTIA is a prospective, event-driven observational study. It aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in patients after acute cryptogenic stroke and transient ischemic attack (TIA).
Detailed description
It will be enrolled 250 participants of both sexes within two weeks after diagnosed cryptogenic stroke and/or TIA at Akershus University Hospital, Oslo area, Norway.
Evaluation of participants' comorbidity with CHADS2-VASc score, ECG, Holter ECG, echocardiography, detection of biochemical cardiac markers and screening for obstructive sleep apnea syndrome will be performed. All participants will be monitored with a continuous cardiac rhythm during one year by implantation of implantable cardiac rhythm monitors (ICRM). All patients without high bleeding risk will get prescribed oral anticoagulants (OAC) after detection of PAF.
A biobank will be established in order to store the sampled biological material.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cryptogenic stroke and TIA | – | Device: Implantation of ICRMImplantation of ICRM in all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 250 participants of both sexes included at Akershus University Hospital, Norway, within two weeks after diagnosed with cryptogenic stroke and/or TIA.
Key inclusion criteria (1 listed)
- Patients diagnosed with cryptogenic stroke and/or TIA, in accordance to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification.
Key exclusion criteria (5 listed)
- Patients with known or newly detected AF on initial examination including 24 h Holter ECG.
- Patients on oral anticoagulants (OAC) for non-AF indications.
- Patients with strong contraindications for OAC, even if the presence of underlying AF is detected.
- Patients with atrial- or ventricular thrombi, or atheromas of the aortic arch greater than 4 mm, detected by transesophageal echocardiography.
- Patients unable to sign the informed consent or with a life expectancy due to comorbidities of less than two years.
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 |
|---|---|---|
| Implantation of ICRMAll patients will be implanted with ICRM in order to detect an occult PAF. | Device | Patients with cryptogenic stroke and TIA |
Primary outcome
Detection of paroxysmal atrial fibrillation
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Derived from this study: PubMed 40436433Skrebelyte-Strom L, Saberniak J, Bjorkan Orstad E, Mykland Hilde JE, Ronning OM, Steine K. Left atrial appendage function by strain and structure is associated with thromboembolic risk in patients with cryptogenic stroke and TIA. Open Heart. 2025 May 27;12(1):e003287. doi: 10.1136/openhrt-2025-003287.
- Derived from this study: PubMed 35819199Skrebelyte-Strom L, Ronning OM, Dahl FA, Steine K, Kjekshus H. Prediction of occult atrial fibrillation in patients after cryptogenic stroke and transient ischaemic attack: PROACTIA. Europace. 2022 Dec 9;24(12):1881-1888. doi: 10.1093/europace/euac092.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Stroke and Atrial Fibrillation, run by University Hospital, Akershus at 1 site in Norway.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 10 Sep 2018. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection of paroxysmal atrial fibrillation (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725944, which also lists 2 linked publications.
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 10 Sep 2018.