Reperfusion of digital vasculature in SSc and pRP patients (1)
Research type
Research Study
Full title
Reperfusion of the hands in those with primary and secondary RP after cold challenge in relation to pulsitality of the forearm arteries compared to normal individuals
IRAS ID
143511
Contact name
Kevin Howell
Contact email
Sponsor organisation
Kings College Hospital NHS Foundation Trust
Research summary
This scientific investigation involves the analysis of humans afflicted by well established disease processes. One of the aims of this study is to hopefully elucidate a significant relationship between two parameters that will reveal a stark difference between two separate medical conditions that are similar upon initial presentation. Even if no relationship is found, a sound avenue of investigation has been positively eliminated leading to better directed focus on other lines of research in the future. For these reasons this study presents a good level of validity.
This observational study will use 3 groups of 20; one pRP group, one RP secondary to SSc and a healthy control group. The female:male ratio of each group will be 4:1 to relate to the real spread of this condition across the sexes. Due to the variability in age of onset of RP and SSc all subjects will be aged between 20 and 60. Those with diabetes will not be eligible for the study due to the potential for arterial calcification that increases PI and hampers sonography. Smokers will also be excluded. Participants will be asked to stop taking any medication prescribed for RP before midnight the day prior to testing. Also told not to have a heavy meal or anything hot to drink the morning testing is to occur.
Temperature controlled room at 23oC ± 1oC will be used. Participants sit down for 20 minutes to acclimatize. Subjects then have the PI of their radial and ulnar arteries determined via ultrasonography. Measurement will be taken 10cm proximally from the wrist. PI will be quantified with pulsed wave Doppler while ensuring a Doppler angle of between 30o and 60o. The participant will then undergo cold challenge. Hands will be immersed in a waterbath at 15oC for 1 minute. Reperfusion monitored with FLIR A320G thermography camera over a course of 15 minutes
Potential subjects will be identified by qualified study staff from patients who are attending their routine clinic, review of patient notes and by performing a search on patient databases. Participants for the healthy control group will be recruited from staff of the RFH providing they have no history of oversensitivity to cold and meet the inclusion criteria.
REC name
London - Westminster Research Ethics Committee
REC reference
14/LO/1433
Date of REC Opinion
23 Sep 2014
REC opinion
Further Information Favourable Opinion