"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)" (NCT01025947) | Clinical Trial Compass
TerminatedNot Applicable
"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"
Stopped: Responsible party does not work at UV anymore
Spain100 participantsStarted 2009-03
Plain-language summary
STUDY TYPE:
Prospective, national , multicenter, and observational study.
OBJECTIVE:
To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.
DEVICE:
Reveal XT 9529 (SQDM)
SAMPLE SIZE AND STUDY DURATION:
100 patients enrolled which will be followed during a period of 2 years.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients included must meet one of these two conditions:
* Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
* First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
* All patients must meet all of the following:
* The patient has been implanted an ILR within 30 days after qualifying event
* Age between 45-85 years
* No stenosis \>50% in any arterial vessel corresponding to the affected territory
* Normal Echocardiography
* Normal 24 hours EKG Holter recording
* Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)
* Acceptance and signature of Patient Informed Consent.
Exclusion Criteria:
* All patients included cannot meet any of the following conditions:
* Recurrent stroke or TIA
* Stroke or TIA with determined etiology according to TOAST criteria.
* Anticoagulation indication at the time of enrollment in the study.
* Total contraindication for anticoagulation therapy
* Atrial fibrillation detection prior to enrollment
* Severe cognitive impairment or dementia
* Patient unable to be followed up
* Patients enrolled in another clinical trial
* Patients with life expectancy of less than 1 year
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.
Timeframe: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.