Neurostimulation to Treat Refractory Angina Pectoris Pain

Overview

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.

Full Title of Study: “STARTSTIM – Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single
  • Study Primary Completion Date: April 2007

Interventions

  • Device: Spinal Cord Stimulation

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MedtronicNeuro
  • Provider of Information About this Clinical Study
    • Medtronic Neuromodulation, Medtronic Neuromodulation
  • Overall Official(s)
    • Douglas Zipes, Principal Investigator, Indiana University School of Medicine
    • Nelson Svorkidal, Principal Investigator, Health Science Center, Winnipeg CANADA

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