About the study
A feasibility study of exercise rehabilitation for people who have had a spontaneous coronary artery dissection.
What we are trying to find out
A spontaneous coronary artery dissection (SCAD) is a tear in the wall of a coronary artery. It is an uncommon cause of heart attack, and it affects a different group of people from most heart disease — often younger, and frequently people who were previously fit and well. Because of that, standard cardiac rehabilitation advice does not necessarily fit.
The main aim of this study is to assess the feasibility of an exercise rehabilitation programme for people who have had a SCAD: whether such a programme can be delivered, and whether people are willing and able to take part in it.
Alongside that we are running a feasibility randomised controlled trial with a control group, to explore the direction of effect and the acceptability of a remote exercise intervention in SCAD survivors. This tests the study procedures themselves, so that a future multi-site clinical trial can be designed properly and its size calculated correctly.
This is a feasibility study. It is not designed to prove whether the exercise programme works — it is designed to find out whether the larger trial that could answer that question is worth running, and how to run it.
What this website is for
Understanding whether an exercise programme is feasible means knowing what people’s activity actually looks like day to day — not just what they report at a clinic appointment.
This website collects that record. At an appointment, a member of the study team sits with the participant and connects their Fitbit data, and the study then retrieves the 90 days leading up to their final assessment.
This applies to participants in both groups. If you have been allocated to the control group you will still be asked to connect your device, because comparing the two groups is the entire point — the activity record from the control group is just as important as the record from the exercise group.
What is collected, how it is stored and what your choices are is set out in the Privacy notice.
Who is running the study
The principal investigators are:
- Professor David Adlam — Professor of Cardiology at the University of Leicester and Clinical Cardiologist at University Hospitals of Leicester.
- Dr Coral Hanson — Senior Research Fellow at Edinburgh Napier University and Honorary Fellow at the University of Leicester.
Both have a special interest in spontaneous coronary artery dissection.
The study is sponsored by the University of Leicester and runs through the SCAD clinic at University Hospitals of Leicester, as a collaboration between the University of Leicester, Edinburgh Napier University and the University of the West of Scotland.
Funding
This research is funded by Heart Research UK, a national charity dedicated to funding research into the prevention, treatment and cure of heart disease.
Heart Research UK is a registered charity in England and Wales (no. 1044821) and Scotland (no. SC053550).
Approval and contact
The study proposal has been reviewed and given a favourable opinion by an NHS Research Ethics Committee (reference 24/EE/0253).
Questions about the study can go to Dr Coral Hanson — coral.hanson@napier.ac.uk. Questions about how your data is handled are answered in the Privacy notice, which also gives the Data Protection Officer’s details.