Screening and Eligibility

Screening

Q. What is the best place to start looking for patients?

A. Start with patients that have 2 of the 3 inclusion criteria known (e.g. known coronary artery disease and low LV function).

 

Q. What is the best way to approach patients found on heart failure databases?

A. Arrange their next clinic appointment so that they can be seen by both the PI and research nurse at the same time. It can help if the patient is spoken to face-to-face before they are given the information sheet.

 

Q. What is the best way to keep track of patients at different points in the work-up process?

A. This can be done in many ways and you will soon find what works best for you. From current experience, it has been found helpful to keep a folder or electronic log of potential patients that keeps track of which screening tests have been done, which are still needed and the next time the patient will be seen. An excel spreadsheet can be provided by the CTU that can be used to perform this task. Frequent meetings between the research nurse and PI are also useful to keep track of everything and ensure patients progress towards enrolment in REVIVED.
 

 

Viability

Q. Can patients who have viability but also have ischaemia be included? If so and ischaemia is present, is there a cut off for the amount of ischaemia that is present?

A. Yes, patients with ischaemia can be included. You only need to demonstrate viability to get in the study but going on to look for ischaemia is encouraged where possible (i.e. going on to high dose dobutamine on stress echo or adenosine perfusion MRI). There is no recommended ischaemia cut off but the MDT can use the information if they wish.

 

Q. Can myocardial perfusion scans be used instead of DSE or MRI to assess viability?

A. Yes, all modalities for viability assessment can be used.

 

Q. Can a FDG-PET scan be used instead of DSE or MRI to assess viability?

A. Yes, all modalities for viability assessment can be used.

 

MI

 

Device Implantation

Q. Is implantation of an ICD required for the trial?

A. No, ICD therapy is recommended by both NICE and ESC guidelines for standard care. Most patients will already have an ICD implanted. If a patient is due to have an ICD implanted, it is recommended that this is before randomisation. If a patient does not have an ICD, they can still be entered into the trial.

 

Q. Should there be a wait after implanting a CRT to see if LVEF is improved by CRT alone?

A. No, it has been decided not to include a mandatory delay between CRT implantation and randomisation. Although there is a chance that LVEF will be improved by CRT alone, given that the threshold has been set low there is not much concern that it will result in a cohort whose risk have been improved by CRT. Even if there is some change over time, no delay shouldn’t introduce bias since new implants are likely to be balanced between the two arms.

 

MDT Meetings

 

Q. Could the situation arise where all the screening is done, the patient is randomised and PCI is seen as unfeasible?

A. No, the patient must have been adjudicated as being an acceptable candidate for angioplasty by the MDT before randomisation.

 

Q. What is the advice on including patients with CTOs?

A. If there is a high risk of the procedure being a failure, don’t include the patient but if it is likely that the procedure will be a success, there is no reason to exclude the patient.

 

Q. Can patients with left main stem disease be enrolled?

A. Yes, If successful revascularisation is likely to be achievable, the patient can be included in the trial. In fact, it is important that eligible patients with LMS disease are not excluded as this could bias the outcome of the trial.

 

Q. Is there an upper time limit for the qualifying angiogram or viability assessment?

A. No. The MDT will assess the angiogram and viability assessments and if the information is considered to be clinically relevant can be used. Only the qualifying echo has an upper time limit, of 6 months.