Completed projects
An alphabetical list of all completed trials and studies undertaken by the Cardiovascular Research Unit.
Most of our research relies on the generosity of patient volunteers.
If you would be interested in helping, email cvru@sheffield.ac.uk or call +44 114 226 6159.
A
AIR Study
A study to examine the effect that P2Y12 inhibitors have on the systemic inflammatory system and the prothrombotic effects. 30 healthy volunteers were randomised to either ticagrelor, clopidogrel or no antiplatelet medication. Systemic inflammation was induced with an intravenous injection of Escherichia coli endotoxin. The results of the study demonstrated that platelets play a critical role in inflammation induced by bacterial endotoxin, inhibiting multiple inflammatory and prothrombotic mechanisms.
The ApoJ-ETT Study
To establish whether the levels of biomarker Apo-J-Glyc Change in patients with obstructive coronary artery disease during exercise compared to a control group, with no coronary artery disease. We recruited 25 patients with symptoms of angina, associated with obstructed coronary artery disease. The control group includes 15 patients with non-cardiac chest pain and no evidence of coronary artery disease.
Patients were asked to exercise on a treadmill in the Diagnostic Cardiology Department at The Northern General Hospital. We inserted a cannula shortly before exercise which we used to take blood samples at multiple time points throughout the day.
C
CHEST MI
An observational study to determine the prevalence of the lung disease COPD in patients hospitalised for acute myocardial infarction with a significant history of smoking. For this study, we recruited 216 South Yorkshire patients and followed them up for 1 year.
The results are expected soon.
CLEAR SYNERGY
A randomised controlled multicentre trial to determine the long-term effects of colchicine and spironolactone in patients following a myocardial infarction and percutaneous coronary intervention (PCI).
We are awaiting the results of this study.
Learn more about CLEAR SYNERGY
D
DAPA-MI
A randomised, double-blind, placebo-controlled cardiovascular outcomes trial to evaluate the effect of dapagliflozin in patients without diabetes who suffered myocardial infarction. This study was conducted in the UK and Sweden. Over 2800 UK patients were included in the study, with 137 of these recruited in Sheffield. The results were presented at the American Heart Association annual congress in November 2023.
DAL-GENE
A placebo-controlled study, in which participants recently hospitalised with ACS were genetically profiled. A predetermined group of patients were then randomised to either dalcetrapib or placebo. A total of 6147 patient were randomised across the study.
E
e-ULTIMASTER
A multicentre observational registry to validate the safety and efficacy of the ultimaster drug eluting stent. Providing a research basis for further use of the stent. 37,000 patients were included in the registry across 462 sites worldwide. The CVRU team recruited 222 patients to e-ULTIMASTER with the help of our colleagues in the Sheffield Teaching Hospitals Cardiology department.
View the results of the registry can be found here
H
HERITAGE
This study aimed to characterise the prevalence and distribution of Lipoprotein(a) levels among patients with established cardiovascular disease. Patients over the age of 18 with a history of heart attack, stroke or peripheral artery disease were included in this observational study. Some participants then went on to participate in the HORIZON study.
L
LIBERATES
150 patients with pre-admission diagnosis of type 2 diabetes were recruited to the LIBERATES study following a heart attack. This study took place in several centres across the UK including Sheffield, Leeds and Hull. The study compared the use of continuous glucose monitoring using the Freestyle Libre Glucose Monitoring system, with standard self monitoring of blood glucose. Patients attended four clinic visits to assess their progress during the 91-day trial. The study showed that continuous glucose monitoring can reduce the length of time people spend with abnormally low blood sugar levels.
P
PENNY PCI
20 patients requiring PPCI after presentation to hospital for a heart attack were recruited to PENNY PCI. This was a pilot study, investigating the effects of an enoxaparin drip in patients presenting with acute heart attacks and undergoing emergency treatment with primary percutaneous coronary intervention (PPCI). The study ran for 18 months from August 2017. We found that an enoxaparin infusion post PPCI may be suitable to protect patients from acute stent thrombosis when treated with opiates such as morphine.
PENNYWISE
We set up and performed the PENNYWISE feasibility study, following on from the work on PENNY PCI. We tested our enoxaparin treatment in comparison to standard-of-care intravenous antiplatelet therapy. From June 2018 we recruited 100 patients presenting to The Northern General Hospital for PPCI, pretreated with opiates.
S
SENIOR RITA
A trial comparing an initial conservative treatment strategy (medication alone) and invasive treatment strategy (inpatient coronary angiography) for non-ST-elevation heart attacks, in patients ≥75 years old. SENIOR-RITA is currently in the follow-up phase. The study will be completed March 2024.
STEEL-PCI
A study comparing two dose regimens of ticagrelor with clopidogrel, in patients undergoing PCI for stable coronary artery disease. 174 patients kindly helped out with this research study in Sheffield. The results showed that both ticagrelor doses have a higher and more predictable effect on inhibition of platelets compared to standard treatment with clopidogrel. Ticagrelor had no detectable effect on cellular adenosine uptake.
U
e-ULTIMASTER
A multicentre observational registry to validate the safety and efficacy of the ultimaster drug eluting stent. Providing a research basis for further use of the stent. 37,000 patients were included in the registry across 462 sites worldwide. The CVRU team recruited 222 patients to e-ULTIMASTER with the help of our colleagues in the STH Cardiology department.
W
WILLOW ACS
Between 2016 and 2017, the WILLOW ACS study compared the measurable effects on thrombosis of a new dosing regimen of the antiplatelet drugs aspirin and ticagrelor with the current standard dose. 20 patients already receiving aspirin and ticagrelor for the treatment of acute coronary syndromes (heart attack or unstable angina) kindly took part in the study.
WILLOW CCS
A study comparing the pharmacodynamic effects of three different regimens of antithrombotic therapy with aspirin +/- low-dose rivaroxaban in patients with chronic coronary syndromes. This study completed recruitment in Autumn of 2023 and will have results by the end of 2023.
WILLOW TREE
A study to determine the impact of a lower dose of aspirin, with or without aspirin on the innate immune response to endotoxin. 72 healthy volunteers between the ages of 18-65 years were randomised to this hybrid parallel-group crossover study. During the study, two doses of bacterial endotoxin were administered to participants to model inflammation within the body. This allowed us to compare the anti and proinflammatory effects of the study drugs, aspirin and ticagrelor.
The initial results were presented at the European Society of Cardiology annual conference in August 2023, showing that ticagrelor reduces the inflammatory response to endotoxin and aspirin may block this effect of ticagrelor.
Most of our research relies on the generosity of patient volunteers.
If you would be interested in helping, you can email cvru@sheffield.ac.uk or call +44 114 2266159