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

September 7, 2018 updated by: Loreta Skrebelyte-Strøm, MD, University Hospital, Akershus

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Oslo, Akershus, Norway, 1478
        • Loreta Skrebelyte-Strøm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cryptogenic stroke and TIA
Implantation of ICRM in all participants.
Device: Implantation of ICRM
All patients will be implanted with ICRM in order to detect an occult PAF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of paroxysmal atrial fibrillation
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2016

Primary Completion (Actual)

June 18, 2018

Study Completion (Actual)

June 18, 2018

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/1260 D (REK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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