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

• ClinicalTrials.gov Identifier: NCT02216370
• Recruitment Status: Unknown
• First Posted: August 13, 2014
• Last Update Posted: August 13, 2014
• Sponsor: University Hospital, Martin
• Information provided by (Responsible Party): University Hospital, Martin

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

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

Contacts and Locations

Contacts

Contact: Andrea Petrovicova, M.D.; andrea_petrovicova@post.sk

Locations

Slovakia

Faculty Hospital Nitra; Recruiting

Nitra, Slovakia, 94901

Sponsors and Collaborators

University Hospital, Martin

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Petrovičová A, Kurča E, Brozman M, Hasilla J, Vahala P, Blaško P, Andrášová A, Hatala R, Urban L, Sivák Š. 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.

• Responsible Party: University Hospital, Martin
• ClinicalTrials.gov Identifier: NCT02216370
• Other Study ID Numbers: NRRXT0001
• First Posted: August 13, 2014
• 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:

Stroke; Atrial Fibrillation; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes