Eligibility Criteria
Consent
CRF Completion
Bleeding during or after Surgery
Adverse Events
Admin and General
Eligibility Criteria
Q. Patients with evolving MI are excluded from ART - what is the definition of evolving MI?
A. Patients with ongoing chest pain, ECG and biochemical changes.
Q. Is arrhythmia surgery, for example atrial fibrillation ablation, an exclusion criterion for ART?
A. No, so long as the operation remains a closed procedure (ie no opening of any cardiac chamber).
Q. Can I perform valve procedures or ventriculoplasty with the CABG surgery in ART patients?
A. No, open procedures such as valve surgery or ventriculoplasty are not permitted.
Q. Can I use anastomotic devices in ART patients?
A. No, anastomotic devices are not permitted
Consent
Q. Who is allowed to consent patients into ART?
A. Consent must be taken by the Principal Investigator (PI) at your centre or by another clinician delegated to do so by the PI, providing that person fully understands the ART study procedures. The study co-ordinator plays a vital role in discussing the study with the patient but the responsibility for taking consent remains with the PI.
CRF Completion (Page number order)
Q. What do I enter for “Prior MI” (page 2, q22) if patient has had more than one MI?
A. Please enter the most recent event.
Q. What should I enter for “Ejection fraction” (page 3, q23) if patient has had more than one ventricular function measurement?
A. Please enter the most recent measurement (this should be within 6 months of baseline). If no ventricular function measurement has been taken, please estimate value.
Q. Surgical data (pages 5-7): What do I do if I can’t collect this data?
A. Suggest photocopying relevant pages and send into theatre with the surgeon.
Q. If patient dies in hospital before or after surgery, do I still need to complete CRF pages 5 to 10 (in-hospital section)?
A. Yes please collect all the information you can. If an answer is not applicable, please enter "N/A".
Q. Cardioplegia techniques: What should I enter if more than one technique is used (page 5, q15-17)?
A. Please tick all that apply.
Q. If no blood products are used during surgery (page 5, q20-24) what should I enter?
A. Please enter ‘0’.
Q. If graft type is IMA in situ what should I record for site of proximal anastomosis (page 6, q9)
A. Please enter ‘N/A’.
Q. In the Revascularisation section of the CRF what should I enter for “Time for anastomosis” (page 6, q11)?
A. Please enter time for distal anastomosis only.
Q. What should I enter for duration of ventilation (page 8, q6) if patient comes off ventilation and then is reintubated?
A. Please enter total time of ventilation.
Q. What should I enter if the type of inotropic support (page 8, q8) is not listed in the CRF?
A. Please state type of inotropic support if not listed.
Q. If cardiac enzymes or creatinine are not taken on day 5 (page 8, q23-27), but are taken on either day 4 or day 6, should I enter this data?
A. Yes, please enter either day 4 or day 6 values with the actual date.
Q. What do I do if the patient is still in hospital, following their surgery, at the 6 week follow up?
A. Please enter "patient still in hospital" on page 11 (6 week follow up) and enter "U" for unknown on the CRF pages 11 to 12.
Bleeding during or after Surgery
Q. Post-operatively, if a patient requires blood (or blood products) or surgical intervention because of a bleed, how should I capture this information?
A. Please complete Major Bleed Form. However the discharge summary to accompany the Major Bleed Form is only required when surgical intervention has occurred.
Q. What if patient requires say a couple of units of blood in the days following surgery but doesn’t require surgical intervention for that bleed?
A. You should still complete the Major Bleed form but it is not necessary for you to send a medical summary.
Q. What about blood use during surgery or if the patient has to return to theatre in the immediate post operative period - should I still fill in Major Bleed form?
A. No you don’t need to complete the Major Bleed form as this data will already be captured in the CRF (Page 5, Q18-24 and Page 8, Q5)
Adverse Events
Q. Who do I report SAEs to?
A. All SAEs should be reported to the Clinical Trials and Evaluation Unit who will report to MREC. It is not necessary for individual centres to report events directly to the Chief Investigator.
Q. When should I fill in an “Other SAE” form?
A. Other SAE is defined as “requiring or prolonging hospitalisation” so if the patient stays in hospital longer than expected during their index admission then please complete. Please also complete if patient is admitted to hospital during the 10 year follow-up period.
Q. When should I fill in a “Major Bleed” form?
A. Major Bleed is defined as “requiring the use of blood products or a surgical procedure to deal with the bleed or its sequelae” so if the patient requires blood for any reason (or surgical intervention to deal with the bleed) please complete.
Admin and General
Q. When should I enter a patient onto the screening log?
A. Once you have screened the patient and you know whether they will be participating in ART or not. Please fax to CTEU every week.
Q. When should I use the special white ART envelopes?
A. Please use these for sending the questionnaires to the patients and also for enclosing with the questionnaires so that the patient can return the questionnaires to you. Please use ordinary hospital brown envelopes for sending data to CTEU.
Q. Can my trainee surgeons perform surgery on ART patients?
A. The consultant should always be present during the operation, but we acknowledge that trainees will perform some procedures on ART patients. All surgeons, including trainees, must be registered with the ART study.
Q. When should I follow up patients?
A. Please follow up at 6 weeks and then at one year after surgery and then annually.
