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Neurostimulation to Treat Refractory Angina Pectoris Pain (STARTSTIM)

This study has been terminated.
Information provided by:
MedtronicNeuro Identifier:
First received: September 12, 2005
Last updated: August 26, 2010
Last verified: August 2010
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 Intervention Phase
Angina Pectoris Device: Spinal Cord Stimulation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications

Resource links provided by NLM:

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.

Secondary Outcome Measures:
  • Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.

Estimated Enrollment: 228
Study Start Date: December 2002
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00200070

United States, Florida
Contact Medtronic for Exact Location
Gainesville, Florida, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Massachusetts
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Boston, Massachusetts, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
United States, South Carolina
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Charleston, South Carolina, United States
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Ontario
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Ottawa, Ontario, Canada
Sponsors and Collaborators
Principal Investigator: Douglas Zipes Indiana University School of Medicine
Principal Investigator: Nelson Svorkidal Health Science Center, Winnipeg CANADA
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Neuromodulation Identifier: NCT00200070     History of Changes
Other Study ID Numbers: 1659
Study First Received: September 12, 2005
Last Updated: August 26, 2010

Keywords provided by MedtronicNeuro:
Angina Pectoris Pain

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms processed this record on September 21, 2017