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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN65254102
Date of registration: 12/04/2011
Primary sponsor: South Tees Hospitals NHS Foundation Trust (UK)
Public title: The RASCAL study (Refractory Angina Spinal Cord stimulation and usuAL care) RASCAL
Scientific title: A multicentre randomised controlled trial of Spinal Cord Stimulation plus usual care vs. usual care alone in the management of Refractory Angina: a feasibility & pilot study
Date of first enrolment: May 1 2011
Target sample size: Forty-five (45) Participants over 3 sites.
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN65254102
Study type:  Interventional
Study design:  Pragmatic multi-centre pilot randomised controlled trial  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria: 1. Limiting angina despite optimal anti-angina therapy
2. Canadian Cardiovascular Society Functional Classification of Angina (CCS) Class III and IV
3. Angiographically documented coronary artery disease (CAD)
4. CAD not suitable for revascularisation in the opinion of the referring cardiologist/cardiothoracic surgeon
5. Satisfactory multidisciplinary assessment in accordance with British Pain Society (BPS) guidelines for SCS
6. Demonstrable ischaemia on functional testing

Exclusion criteria: 1. Presence of pacemaker or implanted defibrillator that is incompatible with SCS
2. Patient refusal to participate in the study
3. Presence of co morbidity considered by the assessing clinician to overshadow the effect of the angina or render them an unsuitable candidate for neuromodulation (e.g. advanced spinal disease or deformity)
4. Poor cognitive ability
5. Ongoing anticoagulation therapy, where anticoagulants cannot be safely discontinued without jeopardising patient safety


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Refractory angina
Intervention(s)
Participants will be randomised to receive either a spinal cord stimulator (SCS) with usual care or to receive usual care alone.

One group will therefore have a SCS implanted following a successful trial. Other interventions include exercise tolerance testing, questionnaire completion, physical examination, vital signs recording, females of childbearing potential will undergo pregnancy testing, medical history recording and concomitant and cardiology medication assessment.

Participants allocated usual care, may receive educational sessions with a pain consultant, transcutaneous electrical nerve stimulation (TENs) machines, serial thoracic sympathectomy and oral/systemic analgesics and adjuvant analgesia.
Primary Outcome(s)
HRQoL as measured using the disease-specific measure the Seattle angina questionnaire (SAQ) UK version. We expect the SAQ to be the primary outcome in the definitive trial.
Secondary Outcome(s)
1. Intake of angina medications and angina attacks
2. Exercise capacity (at baseline and 6-months only)
3. Complications and adverse events
4. Healthcare utilisation (e.g. cardiac specific hospitalisations and primary care visits, management of complications/adverse events)
5. Generic measures HRQoL will be assessed using the EuroQol (EQ-5D) and Short Form -36 (SF-36) questionnaires
Secondary ID(s)
Version 2.0/ 20Jan11
Source(s) of Monetary Support
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Ref: PB-PG-1208-18031)
Secondary Sponsor(s)
N/A
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