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Spinal Cord Stimulation (SCS) in Refractory Angina

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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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Angina Pectoris Device: Spinal cord stimulation Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Study on SCS for the Treatment of Refractory Angina Pectoris
Study Start Date : July 2005
Actual Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of angina symptoms [ Time Frame: 1, 3, 6 and 12 months ]
  2. improvement of quality of life [ Time Frame: 1, 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. Improvement of exercise induced myocardial ischemia [ Time Frame: 3, 6 and 12 months ]
  2. evaluation of adverse events and complications [ Time Frame: 0, 1, 3, 6 and 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: March 10, 2009
Last Verified: March 2009

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