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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

251 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-15

Study Completion Date

2018-06-18

Brief Summary

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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).

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Detailed Description

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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

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Cerebrovascular Stroke Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cryptogenic stroke and TIA

Implantation of ICRM in all participants.

Implantation of ICRM

Intervention Type DEVICE

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

Interventions

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Implantation of ICRM

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No