Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121654
Status:
UNKNOWN
Last Update Posted:
2009-03-10
First Post:
2005-07-14
Brief Title:
Spinal Cord Stimulation SCS in Refractory Angina
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Randomized Study on SCS for the Treatment of Refractory Angina Pectoris
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
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:
The study aims at assessing safety and efficacy of Spinal Cord Stimulation SCS for the treatment of refractory angina pectoris in a single blind prospective multicenter study
Sixty patients with refractory angina with new SCS device implantation will be randomized to one of three treatment groups
paresthesic SCS
subliminal SCS
low non effective stimulation control
Clinical follow-up will be done at 1 and 3 months Control group patients will then be randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be reassessed at 6 months
Sixty patients with refractory angina with new SCS device implantation will be randomized to one of three treatment groups
paresthesic SCS
subliminal SCS
low non effective stimulation control
Clinical follow-up will be done at 1 and 3 months Control group patients will then be randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be reassessed at 6 months
Detailed Description:
Aim of the study is to assess safety and efficacy of Spinal Cord Stimulation SCS for the treatment of refractory angina pectoris in a single blind prospective multicenter study The study also assesses whether subliminal SCS may be as effective as paresthesic SCS in these patients
Sixty consecutive patients with refractory angina with a new SCS device implantation will be randomized to one of three treatment groups
paresthesic SCS group 1
subliminal SCS 75-80 of paresthesic threshold group 2
low stimulation consisting of an hour of SCS a day at 005 mV intensity which does not have any significant stimulator effect sham stimulation group 3
Study Procedure
Medical history clinical data drug therapy Angina Canadian Cardiovascular Society CCS classification Seattle Angina Questionnaire SAQ quality of life estimation by EuroQoL scale detailed evaluation of angina attacks frequency intensity duration of episodes nitrates assumption according to a structured diary number of hospitalizations emergency room ER admissions and cardiological visits in the previous 6 months and treadmill exercise stress test results will be obtained at the baseline visit
Patients fulfilling inclusion criteria will undergo SCS implant During the implant stimulation tests will be performed to check paresthesic coverage of angina pain chest area
Patients with adequate paresthesias will be randomized to one of the 3 groups Follow-up visits will be performed at 1 3 6 and 12 months after the SCS implant Drug therapy will not be changed at least during the first 3 months
Patients assigned to group 2 subliminal SCS and those assigned to group 3 sham SCS will be blinded about the assigned treatment
After the 3 months group 3 patients will be randomized to group 1 or group 2 and reassessed at 6-month follow-up comparison between paresthesic versus subliminal SCS
The controlled study will end at the 6-month follow-up when each investigator will decide for the best stimulation for individual patients Every patient will then be followed until 12 months from SCS implant
Clinical assessment will be done at each follow-up visit Exercise stress test results will be repeated at 3- 6- and 12-month follow-up visits
Sixty consecutive patients with refractory angina with a new SCS device implantation will be randomized to one of three treatment groups
paresthesic SCS group 1
subliminal SCS 75-80 of paresthesic threshold group 2
low stimulation consisting of an hour of SCS a day at 005 mV intensity which does not have any significant stimulator effect sham stimulation group 3
Study Procedure
Medical history clinical data drug therapy Angina Canadian Cardiovascular Society CCS classification Seattle Angina Questionnaire SAQ quality of life estimation by EuroQoL scale detailed evaluation of angina attacks frequency intensity duration of episodes nitrates assumption according to a structured diary number of hospitalizations emergency room ER admissions and cardiological visits in the previous 6 months and treadmill exercise stress test results will be obtained at the baseline visit
Patients fulfilling inclusion criteria will undergo SCS implant During the implant stimulation tests will be performed to check paresthesic coverage of angina pain chest area
Patients with adequate paresthesias will be randomized to one of the 3 groups Follow-up visits will be performed at 1 3 6 and 12 months after the SCS implant Drug therapy will not be changed at least during the first 3 months
Patients assigned to group 2 subliminal SCS and those assigned to group 3 sham SCS will be blinded about the assigned treatment
After the 3 months group 3 patients will be randomized to group 1 or group 2 and reassessed at 6-month follow-up comparison between paresthesic versus subliminal SCS
The controlled study will end at the 6-month follow-up when each investigator will decide for the best stimulation for individual patients Every patient will then be followed until 12 months from SCS implant
Clinical assessment will be done at each follow-up visit Exercise stress test results will be repeated at 3- 6- and 12-month follow-up visits
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