The RASCAL study (refractory angina spinal cord stimulation and usual care)

• Register: ISRCTN
• Last refreshed on: 8 January 2018
• Main ID: ISRCTN65254102
• Date of registration: 12/04/2011
• Prospective Registration: Yes
• Primary sponsor: South Tees Hospitals NHS Foundation Trust (UK)
• Public title: The RASCAL study (refractory angina spinal cord stimulation and usual care)
• 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: 01/05/2011
• Target sample size: 45
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN65254102
• Study type: Interventional
• Study design: Pragmatic multi-centre pilot randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Sam Eldabe

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: Both

Health Condition(s) or Problem(s) studied

Refractory angina
Circulatory System
Angina pectoris

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