NCT00121654

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 10, 2009

Status Verified

March 1, 2009

Enrollment Period

3.4 years

First QC Date

July 14, 2005

Last Update Submit

March 9, 2009

Conditions

Angina Pectoris

Keywords

Angina pectorisSpinal cord stimulationRefractory angina pectoris

Outcome Measures

Primary Outcomes (2)

  • Reduction of angina symptoms

    1, 3, 6 and 12 months

  • improvement of quality of life

    1, 3, 6 and 12 months

Secondary Outcomes (2)

  • Improvement of exercise induced myocardial ischemia

    3, 6 and 12 months

  • evaluation of adverse events and complications

    0, 1, 3, 6 and 12 months

Study Arms (3)

1

ACTIVE COMPARATOR

paresthesic SCS

Device: Spinal cord stimulation

2

ACTIVE COMPARATOR

subliminal SCS (75-80% of paresthesic threshold)

Device: Spinal cord stimulation

3

SHAM COMPARATOR

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

Interventions

Spinal cord stimulationDEVICE

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.

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Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto di Cardiologia - Università Cattolica del Sacro Cuore

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Angina Pectoris

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gaetano A Lanza, MD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano A Lanza, MD

CONTACT

+390630154187g.a.lanza@rm.unicatt.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2005

First Posted

July 21, 2005

Study Start

July 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

March 10, 2009

Record last verified: 2009-03

Locations

IT(1)