Qualitative interviews to understand the patient experience of MVA
Research type
Research Study
Full title
Qualitative interviews to understand the patient experience of Microvascular Angina (MVA)
IRAS ID
211218
Contact name
Chloe Tolley
Contact email
Sponsor organisation
Sanofi
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Coronary microvascular angina (MVA) can be defined as angina pectoris (chest pain or discomfort), caused by spasms or other abnormalities within the walls of the small blood vessels that may reduce or limit blood flow to the heart muscle.
Patients with MVA can be separated in two different populations;Population A: patients with stable MVA, defined as symptoms of stable angina pectoris with evidence of myocardial ischemia in the absence of obstructive coronary artery disease
Population B: patients with a history of coronary artery disease and persisting symptoms of angina despite an anatomically successful revascularization and no further indication for revascularization
Sanofi plan to include a patient-reported outcome (PRO) instrument in their upcoming clinical trials to better assess symptoms and impacts of MVA. It is important for any PROs implemented in a clinical trial to assess product efficacy to be developed and validated in line with regulatory guidance.
The objective of the current study is to gain an in-depth understanding of the most important and prevalent symptoms and impacts experienced by MVA patients. This information will ultimately be used to support the selection, potential modification or development of PRO instruments for use in clinical trials to evaluate the efficacy of investigational compounds from a patient’s perspective.
In total, 10 adult patients from the above-mentioned MVA populations will participate in qualitative concept elicitation interviews in the UK in order to explore patients’ experience of living with the disease (including symptoms, treatment and associated impacts of the condition). The interviews will be audio-recorded and then analysed using thematic analysis to identify patterns and trends in the data. In addition to these 10 interviews in the UK, 30 other interviews will be conducted in Germany and the USA.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0416
Date of REC Opinion
17 Oct 2016
REC opinion
Further Information Favourable Opinion