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Neurostimulation to Treat Refractory Angina Pectoris Pain (STARTSTIM)

This study has been terminated.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200070
First received: September 12, 2005
Last updated: August 26, 2010
Last verified: August 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications

Resource links provided by NLM:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200070

Locations
United States, Florida
Contact Medtronic for Exact Location
Gainesville, Florida, United States
United States, Indiana
Contact Medtronic for Exact Location
Indianapolis, Indiana, United States
United States, Massachusetts
Contact Medtronic for Exact Location
Boston, Massachusetts, United States
United States, Minnesota
Contact Medtronic for Exact Location
Minneapolis, Minnesota, United States
Contact Medtronic for Exact Location
Rochester, Minnesota, United States
United States, South Carolina
Contact Medtronic for Exact Location
Charleston, South Carolina, United States
Canada, Manitoba
Contact Medtronic for Exact Location
Winnipeg, Manitoba, Canada
Canada, Ontario
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
  More Information

No publications provided by MedtronicNeuro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Neuromodulation
ClinicalTrials.gov Identifier: NCT00200070     History of Changes
Other Study ID Numbers: 1659
Study First Received: September 12, 2005
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
Angina Pectoris Pain

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013