ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02725944
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Loreta Skrebelyte-Strøm, MD, University Hospital, Akershus

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).

Condition or disease Intervention/treatment
Cerebrovascular Stroke Atrial Fibrillation Device: Implantation of ICRM

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
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and Transient Ischemic Attack
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Detection of paroxysmal atrial fibrillation [ Time Frame: One year ]

Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725944


Contacts
Contact: Kjetil Steine, MD, PhD, ass.professor +4799585554 kjetil.steine@uio.no
Contact: Harald Kjekshus, MD, PhD +4791713821 harald.kjekshus@ahus.no

Locations
Norway
Loreta Skrebelyte-Strøm Recruiting
Oslo, Akershus, Norway, 1478
Contact: Loreta Skrebelyte-Strøm, MD    +4792449186    lors@ahus.no   
Sponsors and Collaborators
University Hospital, Akershus

Responsible Party: Loreta Skrebelyte-Strøm, MD, MD, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02725944     History of Changes
Other Study ID Numbers: 2014/1260 D (REK)
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Loreta Skrebelyte-Strøm, MD, University Hospital, Akershus:
Cryptogenic stroke
Occult paroxysmal atrial fibrillation

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes