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Case study: Study Support Service Case Study -Site Identification

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Study profile and summary

Local Clinical Research Network: North West London
Study name: ISCHEMIA
Type: Non-commercial overseas funder
Funder: National Institute for Health, United States
Number of sites: 30
Recruitment target: 700
Recruitment achieved: 522
Study to close: 15.10.2019

Every year tens of thousands of people in the UK with stable angina have one or more stents inserted to open blockages in their arteries and relieve symptoms such a chest pain. But, except in emergency cases, there is no evidence that treating angina by inserting stents followed by medical and lifestyle interventions is better than medicine and lifestyle changes alone. A research team at Northwick Park Hospital, part of the London North West Healthcare NHS Trust, has led the way in finding out which treatment is better and safer. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (known as the ISCHEMIA trial) opened at the Trust’s Cardiac Research Department four and a half years ago.

“The study is now in its fifth year of recruitment, and with so many patients to maintain in the study, we’ve relied on the support of staff from the Network to maintain our high enrolment rate.”

Network Impact

After opening for recruitment to the ISCHEMIA trial in April 2013, Northwick Park Hospital randomised their first participant just a month later and since then have randomised 196 patients. The hospital rapidly overtook other sites around the world that opened a year earlier and remain at the top globally ever since.

The Cardiac Research Department attribute their success to a number of factors including the support of administration, clinical and research staff. From the research registrars and cardiac physiologists, who perform the stress echocardiograms where most eligible patients for the trial are screened to the cardiac nurses, catheterisation laboratory staff and the cardiothoracic surgeons at the Royal Brompton and Harefield NHS Trust where the surgery is carried out.

Consultant Cardiologist and one of the study’s principal investigators Dr Ahmed Elghamaz says:

“It’s such a complex study and getting patients is actually quite difficult.

“The reason we’ve been so successful is because we are working together very well in all aspects of the study - from the imaging of the heart, to the intervention, to the medical treatment.”

The team’s success means that they took over responsibility for leading the study in the UK, and with the help of the NIHR Clinical Research Network (CRN) North West London they have identified and opened 30 sites, including identifying new sites as the study has progressed. Grace Young, ISCHEMIA’s UK study coordinator, explains:

“The study is now in its fifth year of recruitment, and with so many patients to maintain in the study, we’ve relied on the support of staff from the Network to maintain our high enrolment rate.”

Insight

Dr Elghamaz said the team have been learning from the study even before the study closes next year:

“I am an interventional cardiologist so by nature I like to open up blocked arteries.

Therefore, it was a surprise to me to leave patients with a very severe narrowing of the arteries and find that they are actually doing very well, some of them have gone up to four and a half years now without any need for intervention.”He also feels that the results of the study will be easy to apply in the NHS:

“Studies don’t always follow real life practice but this study is trying really hard to mimic what we would normally do, making the results easier to apply to real life practice.

“By answering the question we don’t know, which is how best to treat patients with stable angina, the ISCHEMIA study is a game changer in the future of cardiology.”