International Study on Syncope of Uncertain Etiology (NCT00120094) | Clinical Trial Compass
TerminatedNot Applicable
International Study on Syncope of Uncertain Etiology
Italy, United Kingdom400 participantsStarted 2002-06
Plain-language summary
This is a multi-center, prospective, observational study enrolling 400 patients with suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt testing and Implantable Loop Recorder (ILR)implantation. In its second phase, which starts after the first ILR-documented syncope, the study will register the patient outcome after administration of ILR-guided therapy, which is left to the discretion of the physicians. The main objective is to verify the value of ILR in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence.
Who can participate
Age range
30 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:
* Suspected or certain neurally-mediated syncope, based on the Guidelines of the ESC TF on Syncope.
* 3 syncope episodes in the last 2 years.
* Severe clinical presentation of syncope requiring treatment initiation in the judgement of the investigator.
* Age \>30 years.
* Patients have undergone carotid sinus massage, and ILR implantation.
Exclusion Criteria:
* ILR not implanted for any reason; in this case, the patients are still followed in the ILR-not implanted group.
* Carotid sinus syndrome.
* Suspected or certain cardiac syncope.
* Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement.
* Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy).
* Steal syndrome.
* Psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator.
* Patient compliance doubtful.
* Patients who are geographically or otherwise inaccessible for follow-up.
* Patient unwilling or unable to give informed consent;
* Pregnancy.
* Life expectancy \< 1 year due to non-cardiac cause
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.