Clinical trial NCT00200070: Neurostimulation to Treat Refractory Angina Pectoris Pain
Official title: STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Angina Pectoris
Keywords: Angina Pectoris Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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)

Primary outcomes:
measure: The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.
Secondary outcomes:
measure: Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Contact Medtronic for Exact Location
state: Florida
city: Indianapolis
country: United States
facility: Contact Medtronic for Exact Location
state: Indiana
city: Boston
country: United States
facility: Contact Medtronic for Exact Location
state: Massachusetts
city: Minneapolis
country: United States
facility: Contact Medtronic for Exact Location
state: Minnesota
city: Rochester
country: United States
facility: Contact Medtronic for Exact Location
state: Minnesota
city: Charleston
country: United States
facility: Contact Medtronic for Exact Location
state: South Carolina
city: Winnipeg
country: Canada
facility: Contact Medtronic for Exact Location
state: Manitoba
city: Ottawa
country: Canada
facility: Contact Medtronic for Exact Location
state: Ontario
Study officials:
affiliation: Indiana University School of Medicine
name: Douglas Zipes
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Science Center, Winnipeg CANADA
name: Nelson Svorkidal
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.