International Study on Syncope of Uncertain Etiology
|ClinicalTrials.gov Identifier: NCT00120094|
Recruitment Status : Terminated
First Posted : July 15, 2005
Last Update Posted : April 11, 2006
|Condition or disease||Phase|
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Study purpose was to verify the value of an Implanted Loop Recorder (ILR) in assessing the mechanism of syncope and the efficacy of ILR-guided therapy after documentation of syncope recurrence in patients with suspected or certain neurally-mediated syncope at initial evaluation.
Multi-center, prospective, observational study enrolling 400 patients with suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt testing and 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.
Main objective: To verify the value of ILR in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence.
- To define the exact mechanism of syncope in patients with suspected or certain neurally-mediated syncope based on the initial evaluation;
- To prospectively evaluate the correlation between tilt-induced syncope, ATP-induced asystolic response and/or carotid sinus hypersensitivity and ILR-documented spontaneous syncope associated with bradycardia and/or asystole;
- To assess the relationship between asymptomatic and symptomatic asystoles;
- To assess the effectiveness of pacing therapy for preventing syncope recurrence in patients implanted with a pacemaker after an ILR-documented syncope associated with asystole/bradycardia.
- 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.
- 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;
- Life expectancy < 1 year due to non-cardiac cause.
Primary endpoints: Phase 1: first ECG-documented syncope Phase 2: first syncope recurrence after implementation of ILR-guided therapy
Secondary endpoints: Phase 1:
- Asymptomatic ILR-documented arrhythmia
- ILR-documented pre-syncope/s
- Total number of syncopal recurrences
- Pre-syncope recurrence
Study duration: ISSUE 2 will enroll a minimum of 400 patients during an anticipated period of 3 years. As the study will continue for a period of 6 months after the enrollment of the last patient, total study duration will be approximately 4 years.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Observational Model:||Defined Population|
|Official Title:||ISSUE 2. The Management of Patients With Suspected or Certain Neurally-Mediated Syncope After the Initial Evaluation|
|Study Start Date :||June 2002|
|Estimated Study Completion Date :||June 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120094
|Department of Cardiology, Arrhythmologic Centre|
|Lavagna, Genova, Italy, 16033|
|Arcispedale S Maria Nuova|
|Reggio Emilia, Italy|
|Royal Brompton Hospital|
|London SW3 6NP, United Kingdom|
|Principal Investigator:||Carlo Menozzi, MD||Department of Interventional Cardiology, Opsedle S Maria Nuova, Reggio Emilia|
|Principal Investigator:||Michele Brignole, MD||Department of Cardiology, Arrhythmologic Centre, Ospedali del Tigullio, Lavagna|
|Principal Investigator:||Richard Sutton, MD||Royal Brompton & National Heart Hospital, London|