This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
September 12, 2005
August 26, 2010
December 2002
April 2007   (Final data collection date for primary outcome measure)
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.
Same as current
Complete list of historical versions of study NCT00200070 on Archive Site
Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.
Same as current
Not Provided
Not Provided
Neurostimulation to Treat Refractory Angina Pectoris Pain
STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Angina Pectoris
Device: Spinal Cord Stimulation
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2007
April 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
Not Provided
Not Provided
Not Provided
Medtronic Neuromodulation
Not Provided
Principal Investigator: Douglas Zipes Indiana University School of Medicine
Principal Investigator: Nelson Svorkidal Health Science Center, Winnipeg CANADA
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP