Clinical Trial: Spinal Cord Stimulation (SCS) in Refractory Angina

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Study on SCS for the Treatment of Refractory Angina Pectoris

Brief Summary:

The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study.

Sixty patients with refractory angina with new SCS device implantation will be randomized to one of three treatment groups:

  • paresthesic SCS;
  • subliminal SCS;
  • low (non effective) stimulation (control).

Clinical follow-up will be done at 1 and 3 months. Control group patients will then be randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be reassessed at 6 months.


Detailed Summary:

Aim of the study is to assess safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study. The study also assesses whether subliminal SCS may be as effective as paresthesic SCS in these patients.

Sixty consecutive patients with refractory angina with a new SCS device implantation will be randomized to one of three treatment groups:

  • paresthesic SCS (group 1);
  • subliminal SCS (75-80% of paresthesic threshold; group 2);
  • low stimulation, consisting of an hour of SCS a day at 0.05 mV intensity, which does not have any significant stimulator effect (sham stimulation, group 3).

Study Procedure

Medical history, clinical data, drug therapy, Angina Canadian Cardiovascular Society (CCS) classification, Seattle Angina Questionnaire (SAQ), quality of life estimation by EuroQoL scale, detailed evaluation of angina attacks (frequency, intensity, duration of episodes; nitrates assumption) according to a structured diary, number of hospitalizations, emergency room (ER) admissions and cardiological visits in the previous 6 months and treadmill exercise stress test results will be obtained at the baseline visit.

Patients fulfilling inclusion criteria will undergo SCS implant. During the implant, stimulation tests will be performed to check paresthesic coverage of angina pain chest area.

Patients with adequate paresthesias will be randomized to one of the 3 groups. Follow-up visits will be performed at 1, 3, 6, and 12 months after the SCS implant. Dru
Sponsor: Catholic University of the Sacred Heart

Current Primary Outcome:

  • Reduction of angina symptoms [ Time Frame: 1, 3, 6 and 12 months ]
  • improvement of quality of life [ Time Frame: 1, 3, 6 and 12 months ]


Original Primary Outcome: Reduction of angina symptoms, improvement of quality of life.

Current Secondary Outcome:

  • Improvement of exercise induced myocardial ischemia [ Time Frame: 3, 6 and 12 months ]
  • evaluation of adverse events and complications [ Time Frame: 0, 1, 3, 6 and 12 months ]


Original Secondary Outcome: Improvement of exercise induced myocardial ischemia; evaluation of adverse events and complications.

Information By: Catholic University of the Sacred Heart

Dates:
Date Received: July 14, 2005
Date Started: July 2005
Date Completion: December 2009
Last Updated: March 9, 2009
Last Verified: March 2009