Validation of TEG 6s in Interventional Cardiology
Research type
Research Study
Full title
Validation of the TEG 6s device for assessment of individual responses to antiplatelet therapy in ischaemic heart disease using the TEG 5000 series as a reference
IRAS ID
166264
Contact name
Nicholas Curzen
Contact email
Sponsor organisation
University Hospital Southampton NHS FT
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
In patients with heart attack or those receiving a coronary stent (stent in a blood vessel supplying the heart), aspirin and clopidogrel are essential to reduce future risk of blood clots within the stent (stent thrombosis or ST) or recurrent heart attacks. These medications (antiplatelet therapy or APT) work by preventing blood particles called platelets from sticking together to form clots. Individual responses to APT vary from person to person and those with a “poor response” have a greater risk of recurrent heart attacks, stroke, ST or death. Modifying APT in those with a “poor response” may reduce the risk of such adverse events however such a strategy would require a platelet function test that is accurate, rapid and easy to perform at the patient’s bedside. The new TEG 6s device is purported to be such a device which has been developed to succeed the TEG 5000 series that has previously been extensively validated for the assessment of individual responses to APT. This study will seek to determine, through a series of blood tests whether the new TEG 6s device can also assess individual responses to APT and to test whether results with the TEG 6s device agree and correlate with those obtained from the TEG 5000 series. In this study we will recruit 36 patients who are taking APT as they are either known to have or suspected of having disease in their coronary arteries (blood vessels supplying the heart). Additionally, we will also recruit 50 healthy volunteers who do not routinely take these or any other medications. The study will be funded by Haemonetics Corporation who manufacture the device. However the study has been independently designed by investigators at the University Hospital Southampton UHS). It will be conducted at the UHS and will take approximately one year to complete.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1278
Date of REC Opinion
12 Mar 2015
REC opinion
Further Information Favourable Opinion