True incidence of definitive stent thrombosis in OHCA (Trust Study)
Research type
Research Study
Full title
Study to investigate the true incidence of definite stent thrombosis in comatose out of hospital cardiac arrest survivors treated with percutaneous coronary intervention and targeted temperature management.
IRAS ID
233865
Contact name
Thomas Keeble
Contact email
Sponsor organisation
Basildon and Thurrock University Hospitals NHS FT
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Why? Coronary artery disease is the leading cause of cardiac arrest (collapse with loss of pulse / heart stopping. In these cases, coronary stent implantation is the treatment of choice, and medication should be administered to ensure the stent remains patent. Reliable data on stent thrombosis (ST) in comatose cardiac arrest survivors is lacking. In comatose cardiac arrest survivors, suspicion of ST can be made with precise clinical monitoring of the patient with definite confirmation being possible only by coronary angiography or post-mortem of deceased patients. However in addition to definite ST (angiography based upon clinical suspicion), clinically silent ST is plausible. These could be identified only by systematic coronary angiography of all OHCA survivors or by post-mortem of deceased patients. Collectively with definite ST confirmed by coronary angiography upon clinical suspicion the incidence of all forms of ST in survivors of OHCA treated with percuntaneous coronary intervention (PCI) could be obtained.
What? The true incidence of definite ST in the specific group of comatose patients is the area of interest.
Who? Consecutive comatose survivors of OHCA treated with PCI will be included.
Where? The study will be conducted at the Essex Cardiothoracic Centre, United Kingdom.
How? All study participants will receive treatment per our established clinical protocol and will be followed up for 10 days. In all patients in whom clinical suspicion of ST will be made immediate coronary angiography and if necessary PCI will be carried out. In all participants that will die in the observed period of 10 days a post-mortem will be performed. Recruitment is estimated to last 18 months.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
18/EE/0155
Date of REC Opinion
10 Jun 2019
REC opinion
Further Information Favourable Opinion