Maximizing Recruitment
in ACST-2
Recruitment to Date
ACST-2
recruitment
to date:
1,709
Clinical trials require VERY
large numbers of patients,
because they study
MODERATE effects…
…therefore we need to
Visit the website for daily recruitment rate:
www.acst-2.org
recruit as many
patients as we can!
TIA/stroke clinics
Stroke inpatients
DETECTION
Vascular outpatients
Screening
Cardiology or cardiothoracic
surgery assessment
WHERE WE FIND TRIAL PATIENTS
Duplex
Doppler
CTA
MRA
Clinician
Patient eligibility
discussed (e.g. MDT)
Patient consent and
entering in trial
Know the Inclusion Criteria
• Tight carotid artery stenosis (>70%), confirmed by duplex ultrasound
• MRA, CTA or Angiogram shows that CEA and CAS are both practicable
• No symptoms or signs* on the IPSILATERAL side for at least 6 months
• Doctor & Patient are uncertain about whether to treat with CEA or CAS
• Patient is fit, willing for follow- up and is likely to live 5 years
• Patient is still eligible even if they’ve had a symptom or sign* on the
CONTRALATERAL side
(*MR/CT infarcts)
Patient Enrolment
• Asymptomatic patients should be given the trial
information leaflet at their FIRST appointment
• Confirm patients are willing to accept
randomisation allocation and obtain the consent
form immediately
• Patients should be able to talk to the same
doctor/ research nurse each time about the trial  give patients a card with your contact details and the trial
name.
Patient- centric Approach:
• Ensure an impartial explanation of BOTH
procedures in the trial: CEA and CAS
• Be aware of using sensitive words like:
– ‘randomization’
– ‘uncertainty’
– ‘clinical trial’
vs
vs
vs
50:50 chance
equal likelihood
clinical study
Think TEAM:
Together Everyone Achieves More
• Encourage Team Work across all disciplines
• Include nurses and junior doctors in your team
and encourage them to take part in the trial
• Enrol a Research Nurse or Trial Co-ordinator
to help run the trial at your site
• Arrange meetings with interested parties and
inform them about the trial (e.g. at your MDT)
Regular Annual follow up
• Assess patients with previous ‘stroke-like’
symptoms who have a suitable stenosis on an
annual basis
If you follow-up patients with >60% stenosis
annually, review records to flag potential
patients.
Useful documents
•
•
•
•
Patient Pathway
Inclusion Criteria
Recruitment Tips
Presenting to Patients
ACST-2 is here to help you!
“ Please do not hesitate to contact
me should you have any questions –
we are here to assist you!”
www.acst-2.org
Email: luisa.teixeira@nds.ox.ac.uk
Telephone: +44 (0) 1865 223074