Maximizing Recruitment in ACST-2

Recruitment to Date

Clinical trials require VERY large numbers of patients,

because they study MODERATE effects…

…therefore we need to recruit as many

patients as we can!Visit the website for daily recruitment rate:

www.acst-2.org

ACST-2recruitment

to date:

1,709

Clinician

Duplex Doppler

CTAMRA

Patient consent and entering in trial

DETECTION

Patient eligibility discussed (e.g. MDT)

TIA/stroke clinics

Stroke inpatients

Vascular outpatients

Screening

Cardiology or cardiothoracic surgery assessment

WHERE WE FIND TRIAL PATIENTSWHERE WE FIND TRIAL PATIENTS

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’ vs 50:50 chance– ‘uncertainty’ vs equal likelihood– ‘clinical trial’ vs 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.orgEmail: luisa.teixeira@nds.ox.ac.uk

Telephone: +44 (0) 1865 223074