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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02216370
• Other study ID #: NRRXT0001
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2014
• Last updated: August 11, 2014
• Start date: April 2014
• Est. completion date: June 2018

Study information

• Verified date: August 2014
• Source: University Hospital, Martin
• Contact: Andrea Petrovicova, M.D.
• Email: andrea_petrovicova[@]post.sk
• Is FDA regulated: No
• Health authority: State Institute for Drug Control ,Slovakia ':'
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryptogenic Stroke or TIA
• Stroke

Locations

Country	Name	City	State
Slovakia	Faculty Hospital Nitra	Nitra

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Martin

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Follow-up of patients with implanted ECG monitor REVEAL XT incidence of atrial fibrillation, stroke or TIA		3 Years	No
Primary	Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 and ZFHX3	Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 chromosome 4q25, polymorphism rs1906591,rs10033464 and ZFHX3 chromosome 16q22, polymorphism rs2106261	12 months	No
Secondary	Time to documented Atrial Fibrillation Reccurent stroke or TIA Stroke Secondary Prevention Therapy changes within 12 months Neuroimaging Changes ( brain CT/ MRI)		12 months	No