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

Phase 4

Completed

• Conditions: Cryptogenic Ischemic Stroke; Cryptogenic Symptomatic Transient Ischemic Attack

• Registration Number: NCT00924638
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-01
• Results First Submitted: 2014-06-26
• Results First Submitted QC: 2014-06-26
• Last Update Submitted: 2014-06-26
• Results First Posted: 2014-07-28
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AF Detection Rate Within 6 Months	6 months	Percentage of subjects with AF detected within 6 months of follow-up

Secondary Outcome Measures

Name	Time	Method
AF Detection Rate Within 12 Months	12 months	Percentage of subjects with AF detected within 12 months of follow-up
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)	12 months	Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up
Use of Oral Anticoagulation (OAC) Drugs	12 months	Percentage of subjects who were using OAC drugs at the 12 months follow-up visit
Use of Antiarrhythmic Drugs	12 months	Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit
Health Outcome as Evaluated by EQ-5D Questionnaire	12 months	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).
Clinical Disease Burden and Care Pathway	12 months	Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months
Impact of Patient Assistant Use on AF Diagnosis	Follow-up closure	AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency

Trial Locations

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

Cardiology Associates Research, LLC; 🇺🇸 Tupelo, Mississippi, United States

Mid America Heart Institute / St. Lukes Hospital; 🇺🇸 Kansas City, Missouri, United States

Washington University Medical School; 🇺🇸 St. Louis, Missouri, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

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