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

NCT ID: NCT02216370

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-06-30

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.

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.

Conditions

Cryptogenic Stroke or TIA; Atrial Fibrillation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cryptogenic Stroke or TIA

No interventions assigned to this group

Healthy Volunteers

Healthy Volunteers as comparative group adjusted to investigated group by age and gender

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Martin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty Hospital Nitra

Nitra, , Slovakia

Site Status: RECRUITING

Countries

Slovakia

Central Contacts

Andrea Petrovicova, M.D.

Role: CONTACT

andrea_petrovicova@post.sk

References

Petrovicova A, Kurca E, Brozman M, Hasilla J, Vahala P, Blasko P, Andrasova A, Hatala R, Urban L, Sivak S. Detection of occult paroxysmal atrial fibrilation by implantable long-term electrocardiographic monitoring in cryptogenic stroke and transient ischemic attack population: a study protocol for prospective matched cohort study. BMC Cardiovasc Disord. 2015 Dec 3;15:160. doi: 10.1186/s12872-015-0160-8.

Reference Type: DERIVED

PMID: 26631084 (View on PubMed)

Other Identifiers

NRRXT0001

Identifier Type: -

Identifier Source: org_study_id