Neurostimulation to Treat Refractory Angina Pectoris Pain (STARTSTIM)
This study has been terminated.
Sponsor:
MedtronicNeuro
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200070
First received: September 12, 2005
Last updated: August 26, 2010
Last verified: August 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | August 26, 2010 | ||||||||
| Start Date ICMJE | December 2002 | ||||||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00200070 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Neurostimulation to Treat Refractory Angina Pectoris Pain | ||||||||
| Official Title ICMJE | STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications | ||||||||
| Brief Summary | The therapy under investigation involves an implanted Medtronic neurostimulation system to relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by an implanted battery. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
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| Condition ICMJE | Angina Pectoris | ||||||||
| Intervention ICMJE | Device: Spinal Cord Stimulation | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Zipes DP, Svorkdal N, Berman D, Boortz-Marx R, Henry T, Lerman A, Ross E, Turner M, Irwin C. Spinal cord stimulation therapy for patients with refractory angina who are not candidates for revascularization. Neuromodulation. 2012 Nov-Dec;15(6):550-8; discussion 558-9. doi: 10.1111/j.1525-1403.2012.00452.x. Epub 2012 Apr 11. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 228 | ||||||||
| Completion Date | April 2007 | ||||||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00200070 | ||||||||
| Other Study ID Numbers ICMJE | 1659 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Medtronic Neuromodulation | ||||||||
| Study Sponsor ICMJE | MedtronicNeuro | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | MedtronicNeuro | ||||||||
| Verification Date | August 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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