LIGHT ON study v1.0
Research type
Research Study
Full title
LIGHT ON - Infrared thermaL imagInG assessment of the normal Human physiological response to cardiac device implantaTiON.
IRAS ID
340877
Contact name
Fadi Jouhra
Contact email
Sponsor organisation
St. George's University Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
This is a pilot study to assess the feasibility and validity of the use of medical thermography in the assessment of cardiac electronic device implant sites in patients undergoing cardiac electronic device implantation at a single high-volume site. One of the risks of having a cardiac implantable electronic device is infection of the device or pocket where the device generator is buried under the skin. Diagnosing of pocket infection is not always straightforward and may involve different tests including blood tests and other scans which may lead to delay in diagnosis. Infection usually results in increase in temperature. We are conducting a pilot study to assess the change, if any, in local skin temperature at the pocket site after someone has a cardiac device implanted, and to assess the effectiveness and reliability of the infrared thermography in patients with an implanted cardiac device. If the study is successful, we will then conduct a further study to assess if infrared thermography will aid in early and accurate diagnosis of cardiac device pocket infections. We aim to recruit 50 patients (equal split between gender) undergoing cardiac implantable electronic implantation in our institution - this includes new implants and generator changes and transvenous and subcutaneous devices. Patients will have thermography imaging obtained prior to implant and further imaging will be obtained a few hours after the procedure and at each device clinic visit which will be 6 weeks, 3 months, and 6 months after the procedure. This will coincide with the time when the patient has a device check.
REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0765
Date of REC Opinion
25 Nov 2024
REC opinion
Further Information Favourable Opinion