Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and TIA

NCT02725944 | Completed

• 1 other identifier: 2014/1260 D (REK)
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cerebrovascular Stroke; Atrial Fibrillation

Keywords

Cryptogenic stroke; Occult paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Detection of paroxysmal atrial fibrillation

  One year

Study Arms (1)

Patients with cryptogenic stroke and TIA

Implantation of ICRM in all participants.

Device: Implantation of ICRM

Interventions

Implantation of ICRM DEVICE

All patients will be implanted with ICRM in order to detect an occult PAF.

Patients with cryptogenic stroke and TIA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

250 participants of both sexes included at Akershus University Hospital, Norway, within two weeks after diagnosed with cryptogenic stroke and/or TIA.

You may qualify if:

• \- Patients diagnosed with cryptogenic stroke and/or TIA, in accordance to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Loreta Skrebelyte-Strøm

Oslo, Akershus, 1478, Norway

Location

Related Publications (2)

• 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.

  PMID: 40436433 DERIVED

• Skrebelyte-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.

  PMID: 35819199 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Stroke; Atrial Fibrillation; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 1, 2016
• Study Start: May 15, 2016
• Primary Completion: June 18, 2018
• Study Completion: June 18, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)