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Detection of Occult Paroxysmal AF in Cryptogenic Stroke or TIA Patients Using an Implantable Loop Recorder and Correlation With Genetic Markers.

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. Read our disclaimer for details. Identifier: NCT02216370
Recruitment Status : Unknown
Verified August 2014 by University Hospital, Martin.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):
University Hospital, Martin

Brief Summary:
Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could be present but not revealed by rutinne ECG.

Condition or disease
Cryptogenic Stroke or TIA Atrial Fibrillation

Detailed Description:
The subcutaneous Insertable Cardiac Monitor - Reveal® XT ICM, which provides long-term monitoring ( for 3 years), in selected stroke and TIA population on the basis of age, stroke etiology, and prescreening for cardiac arrhythmias helps to increase a detection of AF to 16.7% (range, 14.3% to 20.0%) in compare to ambulatory ECG detection of AF 6.4% (range, 5.3% to 9.0%). The AF detection after stroke and TIA strategically changes the therapeutic approach. In correlation with mentioned above the incidence of both specific genetic markers of AF and occurance of AF in this population and healthy volunteers are interesting.

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of Occult Paroxysmal Atrial Fibrillation in Cryptogenic Stroke Patients or TIA Using an Implantable Loop Recorder and Correlation With Genetic Markers.
Study Start Date : April 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Cryptogenic Stroke or TIA
Healthy Volunteers
Healthy Volunteers as comparative group adjusted to investigated group by age and gender

Primary Outcome Measures :
  1. Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 and ZFHX3 [ Time Frame: 12 months ]
    Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 chromosome 4q25, polymorphism rs1906591,rs10033464 and ZFHX3 chromosome 16q22, polymorphism rs2106261

Secondary Outcome Measures :
  1. Time to documented Atrial Fibrillation Reccurent stroke or TIA Stroke Secondary Prevention Therapy changes within 12 months Neuroimaging Changes ( brain CT/ MRI) [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Follow-up of patients with implanted ECG monitor REVEAL XT incidence of atrial fibrillation, stroke or TIA [ Time Frame: 3 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with stroke or TIA confirmed by neurologist within 72 hours of onset symptoms

Inclusion Criteria:

  • 1. Cryptogenic stroke or TIA within 72 h of onset symptoms according to the criteria for the Trial of Org 10172 in Acute Stroke Treatment (TOAST ) 2. National Institute of Health Stroke scale (NIHSS ) score ≤ 15 3. Modified Rankin Scale (mRS ) score ≤ 3 4. Ability and willingness of patients or their relatives or legal representatives to understand study instructions both verbal and written in accordance with ICH GCP and legislation applicable in the Slovak Republic

Exclusion Criteria:

  • 1. Known etiology of stroke or TIA 2. Untreated hyperthyreosis 3. Myocardial infarct within 1 month of onset stroke or TIA 4. Coronary bypass within 1 month of onset stroke or TIA 5. Valvular disease requiring urgent surgery 6. Documented atrial fibrillation or flutter . 7. Patent Foramen Ovale (PFO) 8. Permanent indication to oral anticoagulation therapy 9. Long-term steroid therapy > 30 days 10. Participation in another clinical trial oriented to experimental pharmacologic therapy .

    11. Chronic inflammatory disease ( rheumatoid arthritide, IBD (Inflammatory bowel diseases ), lupus, vasculitis) 12. Severe co-morbidity not likely to complete to follow-up one year 13. Pregnant and breastfeeding women 14. Indication to pacemaker implantation, implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy IPG or ICD implantation 15. Unabillity provide or unconsent with requiring protocol procedures

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 identifier (NCT number): NCT02216370

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Contact: Andrea Petrovicova, M.D.

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Faculty Hospital Nitra Recruiting
Nitra, Slovakia, 94901
Sponsors and Collaborators
University Hospital, Martin
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Martin Identifier: NCT02216370    
Other Study ID Numbers: NRRXT0001
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by University Hospital, Martin:
Cryptogenic stroke /TIA
Atrial Fibrillation
Implantable Loop Recorder
Genetic Mutation
Additional relevant MeSH terms:
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Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes