Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack

NCT02011256 | Completed DMC

• 1 other identifier: S-20130027
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the frequency of atrial fibrillation in patients with transient ischemic attack (TIA). Patients suffering TIA will have their heart rhythm extensively monitored with 72-hour Holter-monitoring and an implantable loop-recorder. Furthermore, the patients will be examined with echocardiography, coronary calcium-score and biomarkers with the purpose to predict which subjects at risk for developing atrial fibrillation.

Conditions

Transient Ischemic Attack; Atrial Fibrillation

Keywords

Transient Ischemic Attack; Atrial Fibrillation; NOTICE; Implantable loop-recorder; Holter-monitoring

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with TIA diagnosed with atrial fibrillation

  All TIA-patients with no prior history of atrial fibrillation (AFLI) will be monitored for AFLI with 1) regular 12-lead ECG 2) 72-h Holter-monitoring and 3) implantable loop-recorder (ILR). If AFLI is diagnosed, then the patients will not receive further monitoring ie. not all patients will get Holter or ILR.

  1 year

Study Arms (1)

Implantable loop-recorder

EXPERIMENTAL

Device: Implantable loop-recorder

Interventions

Implantable loop-recorder DEVICE

All patients not diagnosed with atrial fibrillation with regular ECG or 72-hour Holter-monitoring will receive an ILR for 3 years.

Also known as: Reveal XT, Medtronic Inc.

Implantable loop-recorder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with TIA by a board certified neurologist
• Written consent
• Residents of Funen, Denmark or surrounding islands

You may not qualify if:

• Prior stroke
• Known atrial fibrillation
• Known contraindication for anticoagulant therapy
• Patients already in anticoagulant therapy
• Patients with estimated short life expectancy
• Pregnancy
• Prior TIA with known etiology

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator

Study Sites (1)

Department of Cardiology, Odense Universityhospital

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Ischemic Attack, Transient; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Brain Ischemia; 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 Officials

• Kenneth Pedersen, MD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 13, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

DK (1)