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OpenTrials
Completed

NCT Number: NCT02713048

Sensitive Troponin I in Out-of-hospital Cardiac Arrest

Troponin is a major diagnostic criterion of acute myocardial infarction (AMI) which confirms myocardial damage and necrosis. In out-of-hospital cardiac arrest (OHCA) patients its dynamics and diagnostic value is often controversial and has not been well described. Most of prior studies were retrospective, using first generation troponin assays and assessing only admission troponin. The aim of this work is to correlate dynamics of sensitive troponin I with urgent coronary angiography.

Patients resuscitated after OHCA will be prospectively divided in three groups based on the results of their urgent angiographies. Serial assessment of sensitive troponin I will be obtained over initial 48 hours.

We expect admission troponin will not be predictive of AMI. Over next hours troponin levels will be highest in patients with acute coronary lesion, lower in stable obstructive coronary disease and insignificant in non-obstructive coronary disease. We also expect significant difference in highest values and dynamics of troponin in sub-group with spontaneous reperfusion (TIMI flow 2 and 3) comparing to patients with coronary occlusion (TIMI flow 0 and 1). In patients with non-obstructive disease we expect troponin levels to correlate with duration of cardiac arrest, number of external electric shocks and cumulative dose of adrenaline administered.

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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

  • female and male over 18 years old
  • comatose survivors after out-of-hospital cardiac arrest (OHCA)
  • absence of an obvious non-coronary cause
  • urgent coronary angiography at admittance
  • less than 3 hours from OHCA to first troponin assessment at admittance

Exclusion criteria

  • sub-acute myocardial infarction
  • coronary spasms or in-stent thrombosis within first 48 hours after admission
  • Coronary surgery or death within first 48 hours after admission

Treatment and study plan

Blood Sample Collection

Other

Eight blood samples in each patient within 48 hours to perform Troponin I measurement.

Primary outcomes

  1. Peak Troponin I value

    Time frame: Within 48 hours after hospital admission

    Peak troponin I values will be compared among 3 groups with different coronary anatomy

Secondary outcomes

  1. Admission troponin I value

    Time frame: Within 3 hours of cardiac arrest

    Admission troponin I will be compared among 3 groups with different coronary anatomy

  2. Peak troponin I value in acute coronary syndrome group

    Time frame: Within 48 hours after hospital admission

    Peak troponin I values will be compared among group with coronary artery occlusion and group with spontaneous reperfusion

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Sensitive Troponin I and Coronary Anatomy in Patients With Out-of-hospital Cardiac Arrest

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2016
Registry last updated
Oct 11, 2018

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.

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