Spinal Cord Stimulation (SCS) in Refractory Angina - Full Text View

Purpose

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.

Condition	Intervention	Phase
Angina Pectoris	Device: Spinal cord stimulation	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Randomized Study on SCS for the Treatment of Refractory Angina Pectoris

Resource links provided by NLM:

MedlinePlus related topics: Angina

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

Reduction of angina symptoms [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
improvement of quality of life [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement of exercise induced myocardial ischemia [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
evaluation of adverse events and complications [ Time Frame: 0, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	60
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 paresthesic SCS	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.
Active Comparator: 2 subliminal SCS (75-80% of paresthesic threshold)	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.
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)	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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121654

Contacts


Contact: Gaetano A Lanza, MD	+390630154187	g.a.lanza@rm.unicatt.it

Locations


Italy
Istituto di Cardiologia - Università Cattolica del Sacro Cuore	Recruiting
Roma, Italy, 00168
Contact: Gaetano A Lanza, MD +390630154187 g.a.lanza@rm.unicatt.it

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators


Principal Investigator:	Gaetano A Lanza, MD	Catholic University of the Sacred Heart

More Information


Responsible Party:	Gaetano Antonio Lanza, Università Cattolica del Sacro Cuore, Roma
ClinicalTrials.gov Identifier:	NCT00121654 History of Changes
Other Study ID Numbers:	ITA-SCS1
Study First Received:	July 14, 2005
Last Updated:	March 9, 2009
Health Authority:	Italy: Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:


Angina pectoris Spinal cord stimulation Refractory angina pectoris

Additional relevant MeSH terms:


Angina Pectoris Chest Pain Pain Neurologic Manifestations Nervous System Diseases	Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016