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

NCT02216370 | Unknown

• 1 other identifier: NRRXT0001
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryptogenic Stroke or TIA; Atrial Fibrillation

Keywords

Cryptogenic stroke /TIA; Atrial Fibrillation; Implantable Loop Recorder; Genetic Mutation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to documented Atrial Fibrillation Reccurent stroke or TIA Stroke Secondary Prevention Therapy changes within 12 months Neuroimaging Changes ( brain CT/ MRI)

  12 months

Other Outcomes (1)

• Follow-up of patients with implanted ECG monitor REVEAL XT incidence of atrial fibrillation, stroke or TIA

  3 Years

Study Arms (2)

Cryptogenic Stroke or TIA

Healthy Volunteers

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with stroke or TIA confirmed by neurologist within 72 hours of onset symptoms

You may qualify if:

• \. 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

You may not qualify if:

• \. 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 .
• \. 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

Sponsors & Collaborators

• University Hospital, Martin: lead

Study Sites (1)

Faculty Hospital Nitra

Nitra, 94901, Slovakia

RECRUITING

Related Publications (1)

• 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.

  PMID: 26631084 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Petrovicova, M.D.

CONTACT

andrea_petrovicova@post.sk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

SL (1)