Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

NCT00157742 | Terminated Phase 4

• 1 other identifier: SPIRIT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Angina Pectoris

Keywords

Angina Pectoris; Spinal Cord Stimulation (SCS); Percutaneous Myocardial Revascularisation (PMR); Refractory Angina Pectoris

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

• Angina measured by the CCS class and the patients subjectives observations

• Morbidity/Mortality

• Quality of life

• Medication consumption

• Difference in myocardial perfusion scanning

Interventions

Spinal Cord Stimulation (SCS) PROCEDURE

Percutaneous Myocardial Laser Revascularisation (PMR) PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (1)

Papworth Hospital

Papworth Everard, Cambridge, CB3 8RE, United Kingdom

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Peter Schofield, MD

  Papworth Hospital, NHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2000
• Study Completion: January 1, 2007
• Last Updated: December 16, 2005

Record last verified: 2005-09

Locations

GB (1)