Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

Angina Pectoris Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00157742
• Other study ID #: SPIRIT
• Status: Terminated
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: December 15, 2005
• Start date: September 2000
• Est. completion date: January 2007

Study information

• Verified date: September 2005
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Procedure:
• Spinal Cord Stimulation (SCS)

• Percutaneous Myocardial Laser Revascularisation (PMR)

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital	Papworth Everard	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in total exercice time following SCS compared to PMR at 12 months
Secondary	Angina measured by the CCS class and the patients subjectives observations
Secondary	Morbidity/Mortality
Secondary	Quality of life
Secondary	Medication consumption
Secondary	Difference in myocardial perfusion scanning
Secondary	Myocardial ischemia during exercise treadmill testing
Secondary	Safety profiles