Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke

Medtronic Cardiac Rhythm and Heart Failure447 enrolled

Overview

The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

447

Conditions

Cryptogenic Symptomatic Transient Ischemic Attack Cryptogenic Ischemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke. Exclusion Criteria: 1. Known etiology of TIA or stroke. 2. Untreated hyperthyroidism. 3. Myocardial infarction less than 1 month prior to stroke or TIA. 4. Coronary bypass grafting less than 1 month prior to stroke or TIA. 5. Valvular disease requiring immediate surgical intervention. 6. History of AF or atrial flutter. 7. Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC). 8. Permanent indication for OAC at enrollment. 9. Permanent contra-indication for OAC. 10. Included in another clinical trial. 11. Life expectancy less than 1 year. 12. Pregnant. 13. Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system. 14. Not fit, unable or unwilling to follow the required procedures of the protocol.

Locations (55)

El Camino Hospital

Mountain View, California, United States

South Denver Cardiology / Swedish Medical Center

Denver, Colorado, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Iowa Heart / Ruan Neurology

Des Moines, Iowa, United States

Louisville Cardiology

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

AF Detection Rate Within 6 Months

Percentage of subjects with AF detected within 6 months of follow-up

Time frame: 6 months

Secondary Outcomes

AF Detection Rate Within 12 Months

Percentage of subjects with AF detected within 12 months of follow-up

Time frame: 12 months

Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)

Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up

Time frame: 12 months

Use of Oral Anticoagulation (OAC) Drugs

Percentage of subjects who were using OAC drugs at the 12 months follow-up visit

Time frame: 12 months

Use of Antiarrhythmic Drugs

Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit

Time frame: 12 months

Health Outcome as Evaluated by EQ-5D Questionnaire

EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).

Time frame: 12 months

Clinical Disease Burden and Care Pathway

Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months

Time frame: 12 months

Impact of Patient Assistant Use on AF Diagnosis

AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency

Time frame: Follow-up closure