Skip to main content
OpenTrials
Completed

NCT Number: NCT03312296

Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of definite early ST until day 10

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors Treated With Percutaneous Coronary Intervention and Hypothermia

Acronym: ST OHCA

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2017
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.