INtravascular catHEter Assessment of Released Thrombin (IN HEART)
Research type
Research Study
Full title
Study of the vascular response to percutaneous coronary intervention in patients with non-ST-elevation acute coronary syndromes using intravascular blood sampling (INtravascular catHEter Assessment of Released Thrombin) The IN-HEART study
IRAS ID
202433
Contact name
Robert Storey
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 1 months, 27 days
Research summary
Acute coronary syndromes (ACS), which include heart attacks and severe angina, usually result from the development of blood clot (known as thrombus) at the site of a coronary (heart) artery narrowing, often related to a tear in the lining of the diseased artery wall.
The current standard management of ACS includes a combination of two blood-thinning tablets and an X-ray investigation (coronary angiogram), where appropriate proceeding to insert a stent (wire cage) to open up significant narrowings, a procedure known as percutaneous coronary intervention (PCI). During PCI the blood is thinned further with the intravenous anti-clotting coagulant heparin. Despite this combination of anti-clotting medications, there remains a risk of further blood clot forming and there is evidence that the mechanisms of clotting are still active. However these have not been measured in the area very local to the narrowing. This is important to investigate as local activation of these mechanisms may play a role in further complications, including further heart attacks.
A new catheter device has been developed, the PlaqueTec Liquid Biopsy System, which can collect blood directly from within and along the coronary arteries and so allow measurement of relevant biomarkers.
The proposed study is designed to determine whether there is local activation of clotting mechanisms at the site of coronary artery narrowings despite current standard blood-thinning therapy in patients with a subtype of ACS, non-ST elevation (NSTE)-ACS, and whether this is associated with procedure-related heart damage. Patients undergoing PCI for NSTE-ACS will be asked to have extra blood samples taken before, during and after PCI, and then will be followed up for six months. Those taken during PCI will be using the PlaqueTec catheter.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0458
Date of REC Opinion
19 Aug 2016
REC opinion
Further Information Favourable Opinion