Detection of Occult Paroxysmal AF in Cryptogenic Stroke or TIA Patients Using an Implantable Loop Recorder and Correlation With Genetic Markers.
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ClinicalTrials.gov 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
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Condition or disease |
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Cryptogenic Stroke or TIA Atrial Fibrillation |
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 |

Group/Cohort |
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Cryptogenic Stroke or TIA |
Healthy Volunteers
Healthy Volunteers as comparative group adjusted to investigated group by age and gender
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- 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
- 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 ]
- Follow-up of patients with implanted ECG monitor REVEAL XT incidence of atrial fibrillation, stroke or TIA [ Time Frame: 3 Years ]

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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 |
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:
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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

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 ClinicalTrials.gov identifier (NCT number): NCT02216370
Contact: Andrea Petrovicova, M.D. | andrea_petrovicova@post.sk |
Slovakia | |
Faculty Hospital Nitra | Recruiting |
Nitra, Slovakia, 94901 |
Responsible Party: | University Hospital, Martin |
ClinicalTrials.gov 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 |
Cryptogenic stroke /TIA Atrial Fibrillation Implantable Loop Recorder Genetic Mutation |
Stroke Atrial Fibrillation Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes |