Characteristics of patients with suspected ACS and role of Lp(a)
A prospective non-interventional study describing the clinical characteristics, including lipoprotein(a) [Lp(a)] levels, in patients with suspected acute coronary syndrome (ACS), to assess the association between Lp(a) levels and cardiovascular events
Novartis Pharmaceutical (UK) Ltd
Duration of Study in the UK
1 years, 11 months, 31 days
Lipoprotein(a) (lp(a)) is an independent risk factor for atherosclerotic cardiovascular disease (ASCVD), including heart attack and stroke.
Lp(a) levels are largely determined by genetic factors. Studies have indicated a direct and dose dependent risk association of Lp(a) with ASCVD and calcific aortic disease. Hence awareness of elevated Lp(a) is important as high Lp(a) increases the risk of ASCVD and could inform clinical decision making regarding risk management.
The European Atherosclerosis Society (EAS) published a consensus statement on Lp(a) in ASCVD and aortic stenosis, providing clinical guidance for testing and treating elevated Lp(a) levels. Despite this Lp(a) testing is not routinely performed for suspected Acute Coronary Syndrome (ACS) patients in the UK.
The aim of this study is to describe the demographics, clinical and disease characteristics of patients with suspected ACS by Lp(a) subgroups at South Tyneside and Sunderland NHS Foundation Trust where testing has been implemented into routine practice.
The study design is a single centre, prospective, non-interventional study. Patients presenting to an acute cardiology unit at South Tyneside and Sunderland NHS Foundation Trust with suspected ACS will each have a blood sample collected as part of routine clinical practice to assess Lp(a) levels. Each patient will then be asked if they would like to consent to take part in the study.
Data on the Lp(a) level and patient characteristics of all consenting patients will be collected during the initial presentation to the acute cardiology unit. Data on patient outcomes will be collected only from ACS diagnosed patients for up to one year post initial presentation.
The study is observational meaning there is no change to a patient's routine clinical care. Data in a pseudonymized format will be collected from medical records.
Funding for this study is provided by Novartis Pharmaceutical (UK) Ltd.
London - City & East Research Ethics Committee
Date of REC Opinion
8 Aug 2023