Electrocardiology

Clinical Trials

Participating Studies and Clinical Trials

What is an ECG Core Lab and why is it needed?

ECGs are often taken to confirm inclusion criteria for clinical trials, to determine end points, to assess any long term risks and provide a form of non-invasive assessment that is vital to many clinical trials. Centralisation and interpretation, storage and retrieval of ECGs has several advantages:

C entralisation of ECG reporting in a core lab permits secure central interpretation, storage and retrieval of ECGs used in clinical trials. Centralisation also helps to make communication a simpler, speedier and more efficient process.

A ccuracy of results can be improved. Studies have shown that visual analysis of ECGs by physicians or other qualified individuals can result in wide variations in interpretation and can lead to false positive and negative results. Computerised interpretation and restriction of visual interpretation to a small number of highly trained individuals adhering to strict operating procedures, reduces these types of errors and increases reproducibility and accuracy of results.

R etrieval of data. Centrally located databases provide a secure and easily managed source for ECG storage and retrieval.

E xcellence of ECG processing ensures that clinical trial data is processed to the highest possible standards.

Our ECG Core Lab Clinical Trials Group and the associated Software Development Group has been assessed annually since August 2003 and registered in accordance with the ISO 9001 (2008 revision) quality assurance standard (Intertek is a UKAS accredited body No 0‌14).

Find out more on how to record ECGs

Current Involvement

a) Clinical Trials / Epidemiological Studies

• AIRWAVE
  
• Scottish Family Health Study
• Whitehall II phase 12 Study
  
• GWAS (Genome Wide Association Studies)

b) Collaborative work

• British Regional Heart Study
• Leiden 85+
  
• T-Time Golden Jubilee Collaboration
  
• ELSA Study (Brazil)
• Fabry Study
• Tromso Study 
• LSHTM
• Moli Sani

c) COVID Related Studies

The ECG Core Lab has an involvement in two studies.

• Cisco19 (Cardiac Imaging in SARS Coronavirus disease-19)

The first of these is the Cardiac Imaging in SARS Coronavirus Disease-19 (CISCO-19) which is supported by the Scottish Chief Scientist Office. Although this study is primarily aimed at imaging the myocardium following infection with Covid-19, 12 lead ECGs have been recorded in digital form where possible during an inpatient stay and then 28 days approximately after discharge.

•  COVID-HEART Study

A second study, namely the COVID-HEART Study, is supported by the National Institute for Health Research and the British Heart Foundation. This study aims to characterise the prevalence and extent of myocardial involvement from Covid-19 infection, to assess recovery status at 6 months and to understand the impact on patient quality of life and functional capacity. Digital ECGs will be recorded daily when feasible while study participants are inpatients and then at 6 months following discharge.  Again, the ECG core lab will be looking for ECG changes during and after the initial period of infection.

Find out more about coronavirus research at the University of Glasgow

Some customer comments

I feel we have had a very good relationship with the team. Any problems addressed and sorted promptly. No complaints.