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Neurostimulation to Treat Refractory Angina Pectoris Pain (STARTSTIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200070
Recruitment Status : Terminated
First Posted : September 20, 2005
Last Update Posted : August 30, 2010
Information provided by:

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
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 : December 2002
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

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.

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200070

United States, Florida
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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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Neuromodulation Identifier: NCT00200070     History of Changes
Other Study ID Numbers: 1659
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 30, 2010
Last Verified: August 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