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Spinal Cord Stimulation (SCS) in Refractory Angina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00121654
Recruitment Status : Unknown
Verified March 2009 by Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : July 21, 2005
Last Update Posted : March 10, 2009
Sponsor:
Information provided by:
Catholic University of the Sacred Heart

Tracking Information
First Submitted Date  ICMJE July 14, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date March 10, 2009
Study Start Date  ICMJE July 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
  • 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 Measures  ICMJE
 (submitted: July 14, 2005)
Reduction of angina symptoms, improvement of quality of life.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
  • 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 Measures  ICMJE
 (submitted: July 14, 2005)
Improvement of exercise induced myocardial ischemia; evaluation of adverse events and complications.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Stimulation (SCS) in Refractory Angina
Official Title  ICMJE 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 Description

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. Drug therapy will not be changed at least during the first 3 months.

Patients assigned to group 2 (subliminal SCS) and those assigned to group 3 (sham SCS) will be blinded about the assigned treatment.

After the 3 months group 3, patients will be randomized to group 1 or group 2 and reassessed at 6-month follow-up (comparison between paresthesic versus subliminal SCS).

The controlled study will end at the 6-month follow-up, when each investigator will decide for the best stimulation for individual patients. Every patient will then be followed until 12 months from SCS implant.

Clinical assessment will be done at each follow-up visit. Exercise stress test results will be repeated at 3-, 6- and 12-month follow-up visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Angina Pectoris
Intervention  ICMJE Device: Spinal cord stimulation
Under sterile conditions and local anesthesia, the epidural space is punctured at the level of T5-T6 and a quadripolar electrode catheter is introduced and advanced under X-ray control into the epidural space. A suitable position for the electrode catheter is sought for, corresponding to the site where a prickling sensation (paresthesia) is felt and covers the area of radiation of angina pain under neurostimulation. The electrode catheter is connected to an internal pulse generator placed in a subcutaneous abdominal or gluteal pocket through an extension lead connected to the electrode by subcutaneous tunneling.
Study Arms  ICMJE
  • Active Comparator: 1
    paresthesic SCS
    Intervention: Device: Spinal cord stimulation
  • Active Comparator: 2
    subliminal SCS (75-80% of paresthesic threshold)
    Intervention: Device: Spinal cord stimulation
  • Sham Comparator: 3
    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)
    Intervention: Device: Spinal cord stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2005)
60
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stable angina pectoris refractory to optimal medical therapy, with at least 10 angina episodes in the three weeks previous SCS implant;
  • Documentation of coronary artery disease and reversible myocardial ischaemia;
  • Patient is not a candidate for or refuses surgical or percutaneous coronary revascularization;
  • Availability for follow-up visits;
  • Written informed consent.

Exclusion Criteria:

  • Severe spinal cord diseases that prevent the catheter positioning in the epidural space;
  • No paresthesic coverage of angina pain area during SCS;
  • Unstable angina pectoris;
  • Female patients in fertile age;
  • Enrolment in other studies;
  • Need for anticoagulant therapy;
  • Patients needing diathermy treatment;
  • Life expectancy <12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00121654
Other Study ID Numbers  ICMJE ITA-SCS1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gaetano Antonio Lanza, Università Cattolica del Sacro Cuore, Roma
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gaetano A Lanza, MD Catholic University of the Sacred Heart
PRS Account Catholic University of the Sacred Heart
Verification Date March 2009

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