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Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

This study has been terminated.
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00157742
First received: September 9, 2005
Last updated: December 15, 2005
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Angina Pectoris
Procedure: Spinal Cord Stimulation (SCS)
Procedure: Percutaneous Myocardial Laser Revascularisation (PMR)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Medtronic:

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

Estimated Enrollment: 66
Study Start Date: September 2000
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157742

Locations
United Kingdom
Papworth Hospital
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Medtronic
Investigators
Principal Investigator: Peter Schofield, MD Papworth Hospital, NHS
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157742     History of Changes
Other Study ID Numbers: SPIRIT
Study First Received: September 9, 2005
Last Updated: December 15, 2005
Health Authority: United Kingdom: National Health Service

Keywords provided by Medtronic:
Angina Pectoris
Spinal Cord Stimulation (SCS)
Percutaneous Myocardial Revascularisation (PMR)
Refractory Angina Pectoris

Additional relevant MeSH terms:
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014