Clinical trial NCT02713048: Sensitive Troponin I in Out-of-hospital Cardiac Arrest
Official title: Sensitive Troponin I and Coronary Anatomy in Patients With Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Acute Coronary Lesion
Stable Obstructive Coronary Disease
Non-obstructive Coronary Disease
Keywords: Cardiac arrest
Troponin I
coronary anatomy
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Comatose survivors after out-of-hospital cardiac arrest admitted to UMC Ljubljana

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak Troponin I value
timeFrame: Within 48 hours after hospital admission
Secondary outcomes:
measure: Admission troponin I value
timeFrame: Within 3 hours of cardiac arrest
measure: Peak troponin I value in acute coronary syndrome group
timeFrame: Within 48 hours after hospital admission
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References:
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