STARTSTIM: Medtronic Spinal Cord Stimulation (SCS)

Study of:
Implanted Spinal Cord Stimulator (similar to a TENS unit)

Spinal Cord Stimulation (SCS) is given through a device that is surgically implanted to treat angina that has not responded to usual medical treatments. The therapy works by delivering mild electrical signals to the area of the spinal cord that corresponds to the location of the angina. These electrical signals should ease the sensation of angina by interfering with the transmission of angina pain signals. This study is designed to evaluate how well SCS works on angina, and to find the best level of stimulation. Patients will be randomized (like the flip of a coin) to one of two treatment “doses.” Below lists the general course of events throughout the length of the study.

Entry Criteria:

        Inclusion

• Age 18 and older
• Stable angina due to CAD
• Not able to have bypass or angioplasty

        Exclusion

• Implanted pacemaker or defibrillator
• Any previous TENS unit use
• Unstable angina
• Pregnancy
• Unable to exercise on treadmill

Study Requirements:
Patients with coronary artery disease (CAD) and angina not controlled by medicines who are not able to have coronary artery bypass or angioplasty are eligible for this study.

        Pre-treatment

• Treadmill stress testing (2-3)
• Rest/stress test with Nuclear Imaging (Sestamibi)
• Angina diary
• Health and well-being questionnaires

        Post-treatment

• Treadmill stress testing (x2)
• Rest/stress test with Nuclear Imaging (Sestamibi)
• Angina diaries
• Health and well-being questionnaires
• Device checks

Timothy D. Henry, MD, FACC

Randall K. Johnson, MD, FACC

Anil K. Poulose, MD, FACC

Jay H. Traverse, MD, FACC, FAHA

Karen L. Harvey, RN

For more information about this study or other research studies at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Karen Harvey at 612.863.1661.