Clinical trial NCT03312296: Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors
Official title: Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors Treated With Percutaneous Coronary Intervention and Hypothermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out of Hospital Cardiac Arrest
Stent Thrombosis
Drug Eluting Stent
Therapeutic Hypothermia
Keywords: Stent Thrombosis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Comatose survivors after out-of-hospital cardiac arrest admitted to University Medical Centre Ljubljana

Brief summary: Reliable data on stent thrombosis (ST) in comatose out of hospital cardiac arrest (OHCA) survivors is lacking. In comatose OHCA survivors suspicion of ST can be made with precise clinical monitoring of the patient with definite confirmation being possible only by coronary angiography or autopsy of deceased patients. However in addition to definite ST which can be confirmed using current protocols, additional ST which are clinically silent are plausible. These could be identified only by systematic coronary angiography of all OHCA survivors or by autopsy 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 PCI and hypothermia could be obtained.

Consecutive comatose survivors of OHCA treated with percutaneous coronary intervention (PCI) and hypothermia will be included. All study participants will receive treatment per our established clinical protocol and will be followed 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 patients that will die in the observed period of 10 days autopsy will be performed. Survivors however will have an additional control coronary angiography on 10th day after admission, to assess presence of clinically silent ST.

We expect that the incidence of true definitive ST in comatose OHCA survivors treated with urgent PCI with stenting and hypothermia is greater than one, which is confirmed on the basis of clinical suspicion by angiography or later with autopsy.


Eligibility criteria: Inclusion Criteria:

* Comatose out-of-hospital cardiac arrest survivors admitted to University Medical Centre Ljubljana
* Treated with primary PCI with stenting
* Treated with therapeutic hypothermia.

Exclusion Criteria:

* Younger than 18 years old.

Primary outcomes:
measure: Incidence of definite early ST until day 10
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References:
citation: Noc M, Fajadet J, Lassen JF, Kala P, MacCarthy P, Olivecrona GK, Windecker S, Spaulding C; European Association for Percutaneous Cardiovascular Interventions (EAPCI); Stent for Life (SFL) Group. Invasive coronary treatment strategies for out-of-hospital cardiac arrest: a consensus statement from the European association for percutaneous cardiovascular interventions (EAPCI)/stent for life (SFL) groups. EuroIntervention. 2014 May;10(1):31-7. doi: 10.4244/EIJV10I1A7.
citation: Steblovnik K, Blinc A, Bozic-Mijovski M, Kranjec I, Melkic E, Noc M. Platelet reactivity in comatose survivors of cardiac arrest undergoing percutaneous coronary intervention and hypothermia. EuroIntervention. 2015 Apr;10(12):1418-24. doi: 10.4244/EIJY14M05_02.
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citation: Rosillo SO, Lopez-de-Sa E, Iniesta AM, de Torres F, del Prado S, Rey JR, Armada E, Moreno R, Lopez-Sendon JL. Is therapeutic hypothermia a risk factor for stent thrombosis? J Am Coll Cardiol. 2014 Mar 11;63(9):939-40. doi: 10.1016/j.jacc.2013.09.028. Epub 2013 Oct 16. No abstract available.