Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors

Completed

• Conditions: Drug Eluting Stent; Out of Hospital Cardiac Arrest; Therapeutic Hypothermia; Stent Thrombosis

• Registration Number: NCT03312296
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-17
• Primary Completion: 2021-08
• Status Verified: 2021-09
• Study Completion: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of definite early ST until day 10	10 days

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia