STARTSTIM: Neurostimulation to Treat Refractory Angina Pectoris Pain

• Sponsor: MedtronicNeuro (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00200070
• Collaborator: (none)
• Enrollment: 228
• Locations: 8
• Duration (Months): 52
• Patients Per Site: 28.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris	Device: Spinal Cord Stimulation	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Official Title: STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months. []

Secondary Outcome Measures

1. Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• stable angina pectoris associated with reversible myocardial ischemia and significant coronary artery disease (CAD)

• classified as Canadian Cardiovascular Society (CCS) angina class III or IV

• refractory angina despite receiving optimal/maximal medical treatment

• not a candidate for bypass surgery, angioplasty or stent

Exclusion Criteria:

• not able to perform exercise treadmill testing

• previously received therapeutic transcutaneous electrical nerve stimulation (TENS) (within 2 years) or any spinal cord stimulation (SCS)

• has an implanted pacemaker/defibrillator (ICD)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Medtronic for Exact Location	Gainesville	Florida	United States
2	Contact Medtronic for Exact Location	Indianapolis	Indiana	United States
3	Contact Medtronic for Exact Location	Boston	Massachusetts	United States
4	Contact Medtronic for Exact Location	Minneapolis	Minnesota	United States
5	Contact Medtronic for Exact Location	Rochester	Minnesota	United States
6	Contact Medtronic for Exact Location	Charleston	South Carolina	United States
7	Contact Medtronic for Exact Location	Winnipeg	Manitoba	Canada
8	Contact Medtronic for Exact Location	Ottawa	Ontario	Canada

Sponsors and Collaborators

• MedtronicNeuro

Investigators

• Principal Investigator: Douglas Zipes, Indiana University School of Medicine
• Principal Investigator: Nelson Svorkidal, Health Science Center, Winnipeg CANADA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00200070
• Other Study ID Numbers: 1659
• First Posted: Sep 20, 2005
• Last Update Posted: Aug 30, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Angina Pectoris Pain
• Additional relevant MeSH terms: Angina Pectoris

Study Results

No Results Posted as of Aug 30, 2010