Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120094
Status:
TERMINATED
Last Update Posted:
2006-04-11
First Post:
2005-06-30
Brief Title:
International Study on Syncope of Uncertain Etiology
Sponsor:
Arcispedale Santa Maria Nuova-IRCCS
Organization:
Arcispedale Santa Maria Nuova-IRCCS
Study Overview
Official Title:
ISSUE 2 The Management of Patients With Suspected or Certain Neurally-Mediated Syncope After the Initial Evaluation
Status:
TERMINATED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ILRimplantation 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
Detailed Description:
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
Secondary objectives
1 To define the exact mechanism of syncope in patients with suspected or certain neurally-mediated syncope based on the initial evaluation
2 To prospectively evaluate the correlation between tilt-induced syncope ATP-induced asystolic response andor carotid sinus hypersensitivity and ILR-documented spontaneous syncope associated with bradycardia andor asystole
3 To assess the relationship between asymptomatic and symptomatic asystoles
4 To assess the effectiveness of pacing therapy for preventing syncope recurrence in patients implanted with a pacemaker after an ILR-documented syncope associated with asystolebradycardia
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 eg 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
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-syncopes
Phase 2
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
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
Secondary objectives
1 To define the exact mechanism of syncope in patients with suspected or certain neurally-mediated syncope based on the initial evaluation
2 To prospectively evaluate the correlation between tilt-induced syncope ATP-induced asystolic response andor carotid sinus hypersensitivity and ILR-documented spontaneous syncope associated with bradycardia andor asystole
3 To assess the relationship between asymptomatic and symptomatic asystoles
4 To assess the effectiveness of pacing therapy for preventing syncope recurrence in patients implanted with a pacemaker after an ILR-documented syncope associated with asystolebradycardia
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 eg 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
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-syncopes
Phase 2
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None