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Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

Primary Purpose

Angina Pectoris

Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Spinal Cord Stimulation (SCS)
Percutaneous Myocardial Laser Revascularisation (PMR)
Sponsored by
Medtronic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring Angina Pectoris, Spinal Cord Stimulation (SCS), Percutaneous Myocardial Revascularisation (PMR), Refractory Angina Pectoris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient limiting angina (CCS III or IV) despite maximally tolerated medical therapy Documented coronary artery disease (within the last 9 months prior baseline), which is unsuitable for conventional revascularisation techniques Patient has documented reversible ischemia on nuclear scan (Tc-99 sestamibi) Patient is limited in daily activities, primarily exercice capability, by their angina pain Age 18 or older Patient must understand the therapy and give informed consent Patient must be available for appropriate follow-up times for length of Study Non pregnant woman Exclusion criteria: Not candidate for surgical implantation of SCS and/or not for PMR and/or unable to use SCS device appropriately for treatment Patient who has had one or more major cardiac events within 2 months Patient with myocardial wall thickness< 8 mm in the ischaemic area to be treated as verified by echocardiography Patient with extensive peripheral vascular disease that precludes vascular access required for PMR Patient on intravenous therapy to control their symptoms Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.malignancy patient who has other diseases that are considered of greater clinical significance than the angina pectoris that would impact the ability of the clinician to adequately assess the incremental effects of the trial treatment Patient with ejection fraction of less than 30 % as verified by echocardiography Patient with cause of angina other than coronary artery disease (e.g. syndrome "X" patient) Patient who are unable to perform treadmill exercice test per protocol Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol Patient who has has SCS , a TMLR or PMR procedure in the past Patient with an implanted pacemaker or defibrillator Patient who has medical conditions which may require Magnetic resonance Imaging (MRI) Patient with history of dementia or other persisting mental disorders significantly interfering with ability to cooperate or comply with the requirements of the study or comprehend informed consent Patient with history of Alcohol og Drug abuse

Sites / Locations

  • Papworth Hospital

Outcomes

Primary Outcome Measures

Improvement in total exercice time following SCS compared to PMR at 12 months

Secondary Outcome Measures

Angina measured by the CCS class and the patients subjectives observations
Morbidity/Mortality
Quality of life
Medication consumption
Difference in myocardial perfusion scanning
Myocardial ischemia during exercise treadmill testing
Safety profiles

Full Information

First Posted
September 9, 2005
Last Updated
December 15, 2005
Sponsor
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00157742
Brief Title
Comparison of SCS and PMR in Patients With Refractory Angina Pectoris
Official Title
An Open Single-Centre Parallel Randomised Trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Revascularisation (PMR) in Patients With Refractory Angina Pectoris
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic

4. Oversight

5. Study Description

Brief Summary
Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in patients with Refractory Angina Pectoris. Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR
Detailed Description
The purpose of this open, parallel, single-center prospective, randomised controlled trial is to compare two treatments: Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) and assess their use and longer term effect in patients with Refractory Angina Pectoris.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
Keywords
Angina Pectoris, Spinal Cord Stimulation (SCS), Percutaneous Myocardial Revascularisation (PMR), Refractory Angina Pectoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Spinal Cord Stimulation (SCS)
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Myocardial Laser Revascularisation (PMR)
Primary Outcome Measure Information:
Title
Improvement in total exercice time following SCS compared to PMR at 12 months
Secondary Outcome Measure Information:
Title
Angina measured by the CCS class and the patients subjectives observations
Title
Morbidity/Mortality
Title
Quality of life
Title
Medication consumption
Title
Difference in myocardial perfusion scanning
Title
Myocardial ischemia during exercise treadmill testing
Title
Safety profiles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient limiting angina (CCS III or IV) despite maximally tolerated medical therapy Documented coronary artery disease (within the last 9 months prior baseline), which is unsuitable for conventional revascularisation techniques Patient has documented reversible ischemia on nuclear scan (Tc-99 sestamibi) Patient is limited in daily activities, primarily exercice capability, by their angina pain Age 18 or older Patient must understand the therapy and give informed consent Patient must be available for appropriate follow-up times for length of Study Non pregnant woman Exclusion criteria: Not candidate for surgical implantation of SCS and/or not for PMR and/or unable to use SCS device appropriately for treatment Patient who has had one or more major cardiac events within 2 months Patient with myocardial wall thickness< 8 mm in the ischaemic area to be treated as verified by echocardiography Patient with extensive peripheral vascular disease that precludes vascular access required for PMR Patient on intravenous therapy to control their symptoms Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.malignancy patient who has other diseases that are considered of greater clinical significance than the angina pectoris that would impact the ability of the clinician to adequately assess the incremental effects of the trial treatment Patient with ejection fraction of less than 30 % as verified by echocardiography Patient with cause of angina other than coronary artery disease (e.g. syndrome "X" patient) Patient who are unable to perform treadmill exercice test per protocol Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol Patient who has has SCS , a TMLR or PMR procedure in the past Patient with an implanted pacemaker or defibrillator Patient who has medical conditions which may require Magnetic resonance Imaging (MRI) Patient with history of dementia or other persisting mental disorders significantly interfering with ability to cooperate or comply with the requirements of the study or comprehend informed consent Patient with history of Alcohol og Drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Schofield, MD
Organizational Affiliation
Papworth Hospital, NHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papworth Hospital
City
Papworth Everard
State/Province
Cambridge
ZIP/Postal Code
CB3 8RE
Country
United Kingdom

12. IPD Sharing Statement

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Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

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