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

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 ClinicalTrials.gov 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
228
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00200070
1659
Not Provided
Medtronic Neuromodulation
MedtronicNeuro
Not Provided
Principal Investigator: Douglas Zipes Indiana University School of Medicine
Principal Investigator: Nelson Svorkidal Health Science Center, Winnipeg CANADA
MedtronicNeuro
August 2010

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