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Completed

NCT Number: NCT00924638

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

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.

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Key information

Conditions

Cryptogenic Symptomatic Transient Ischemic Attack Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cryptogenic Ischemic Stroke Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LKH Universitätsklinikum Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.

Exclusion criteria

  • Known etiology of TIA or stroke.
  • Untreated hyperthyroidism.
  • Myocardial infarction less than 1 month prior to stroke or TIA.
  • Coronary bypass grafting less than 1 month prior to stroke or TIA.
  • Valvular disease requiring immediate surgical intervention.
  • History of AF or atrial flutter.
  • Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).
  • Permanent indication for OAC at enrollment.
  • Permanent contra-indication for OAC.
  • Included in another clinical trial.
  • Life expectancy less than 1 year.
  • Pregnant.
  • Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
  • Not fit, unable or unwilling to follow the required procedures of the protocol.

Treatment and study plan

Reveal® XT Insertable Cardiac Monitor

Device

The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.

Other names: Reveal® XT

Primary outcomes

  1. AF Detection Rate Within 6 Months

    Time frame: 6 months

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

Secondary outcomes

  1. AF Detection Rate Within 12 Months

    Time frame: 12 months

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

  2. Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)

    Time frame: 12 months

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

  3. Use of Oral Anticoagulation (OAC) Drugs

    Time frame: 12 months

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

  4. Use of Antiarrhythmic Drugs

    Time frame: 12 months

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

  5. Health Outcome as Evaluated by EQ-5D Questionnaire

    Time frame: 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).

  6. Clinical Disease Burden and Care Pathway

    Time frame: 12 months

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

  7. Impact of Patient Assistant Use on AF Diagnosis

    Time frame: Follow-up closure

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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

CRYptogenic STroke And underLying AF Trial

Acronym: CRYSTAL-AF

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2009
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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