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Case study: Study Support Service - Early Contact and Engagement

Explore and understand how to access the support that is available for your clinical study.

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Study profile and summary

Local Clinical Research Network: East Midlands
Study name: RapidNSTEMI
Type: NIHR non-commercial Partner
Funder: British Heart Foundation

Heart attacks occur when the heart is starved of blood because one of the arteries supplying blood to it becomes blocked. In smaller heart attacks (known as NSTEMI), the coronary artery is not blocked totally. The treatment for such patients involves going to a catheter lab to mechanically open the artery with a wire and place a stent, to try and prevent the artery from becoming completely blocked. Current guidelines recommend this should be performed within 72 hours of admission to hospital. However it is not known whether there would be a greater benefit for higher risk patients to be immediately sent to the catheter lab.

The RapidNSTEMI study will randomise NSTEMI patients at high risk to either be transferred to the catheter lab immediately (within one hour) or to wait within the current recommended time (next available catheter space or within 72 hours). It will look at whether this results in better clinical outcomes for the patient.

This novel study aims to find out how quickly we should manage patients with certain heart attacks and whether in such higher risk patients there is a benefit from going straight to stenting, as opposed to waiting to stabilise the patient on drugs.

“The Clinical Research Network will be supporting this study from idea stage through the research delivery pathway until study closure with the aid of the Study Support Service in the East Midlands.”

Network Impact

The study’s Chief Investigator, Professor Anthony Gershlick, had applied for funding from the British Heart Foundation on two previous occasions and had been unsuccessful. After approaching the East Midlands Clinical Research Network for their support, his third application for funding was granted.

The East Midlands Clinical Research Network helped attribute costs for the grant application according to Attributing the costs of health and social care Research and Development (AcoRD) guidelines. AcoRD provides a framework for the NHS and its partners to identify, recover and attribute the costs of health and social care R&D, in a transparent, and consistent manner.

The grant application was also successful in part due to a reduction in the amount of funding that was being applied for. This occurred after CRN East Midlands identified service support costs and research Part B costs and agreed to fund these activities.

In addition to the funding application, the East Midlands Clinical Research Network was involved in helping Professor Gershlick to identify new sites by sending out an Expression of Interest form and collating responses so that he could identify sites to take part in the study. They are also supporting the Health Research Authority application for the study with the Leicester Clinical Trials Unit (CTU).

Insight

Professor Gershlick comments: “Having a study as a portfolio study is very attractive. There are three centres we have included in this study as a direct result of this.

“CRN East Midlands assisted in both the costing and promotion of the study. Kathryn Fairbrother (Deputy Chief Operating Officer) and Kiran Mistry (Study Support Manager) have been extraordinarily helpful, and in an innovative way.

“For example, working out the cost of a trial or how to achieve the same output for less cost by not asking for ordinary service costs. It’s examples such as these which may seem obvious to them, but not always to us. This makes a big difference to overall costs.”

Kiran Mistry, East Midlands Clinical Research Network, adds: “Working closely with Professor Gershlick and the Leicester CTU for the RapidNSTEMI trial has been a delightful experience.

“We meet up on a regular basis to keep informed of the trial progress and work together to get a better understanding of the trial and its national importance.

“The Clinical Research Network will be supporting this study from idea stage through the research delivery pathway until study closure with the aid of the Study Support Service in the East Midlands.”