Spinal Cord Stimulation (SCS) in Refractory Angina

Angina Pectoris Clinical Trial

Official title:

Randomized Study on SCS for the Treatment of Refractory Angina Pectoris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00121654
• Other study ID #: ITA-SCS1
• Status: Recruiting
• Phase: Phase 4
• First received: July 14, 2005
• Last updated: March 9, 2009
• Start date: July 2005
• Est. completion date: December 2009

Study information

• Verified date: March 2009
• Source: Catholic University of the Sacred Heart
• Contact: Gaetano A Lanza, MD
• Phone: +390630154187
• Email: g.a.lanza[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto di Cardiologia - Università Cattolica del Sacro Cuore	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of angina symptoms		1, 3, 6 and 12 months	No
Primary	improvement of quality of life		1, 3, 6 and 12 months	No
Secondary	Improvement of exercise induced myocardial ischemia		3, 6 and 12 months	No
Secondary	evaluation of adverse events and complications		0, 1, 3, 6 and 12 months	Yes