Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

December 15, 2005 updated by: Medtronic

An Open Single-Centre Parallel Randomised Trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Revascularisation (PMR) in Patients With Refractory Angina Pectoris

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridge
      • Papworth Everard, Cambridge, United Kingdom, CB3 8RE
        • Papworth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Investigators

  • Principal Investigator: Peter Schofield, MD, Papworth Hospital, NHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2005

Last Update Submitted That Met QC Criteria

December 15, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPIRIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Angina Pectoris

Clinical Trials on Spinal Cord Stimulation (SCS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe