Sensitive Troponin I in Out-of-hospital Cardiac Arrest

Completed

• Conditions: Non-obstructive Coronary Disease; Cardiac Arrest; Acute Coronary Lesion; Stable Obstructive Coronary Disease
• Interventions: Other: Blood sample collection

• Registration Number: NCT02713048
• Lead Sponsor: University Medical Centre 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-obstructive coronary artery disease	Blood sample collection	-
Stable obstructive coronary artery disease	Blood sample collection	-
Acute coronary syndrome culprit coronary lesion	Blood sample collection	-

Primary Outcome Measures

Name	Time	Method
Peak Troponin I value	Within 48 hours after hospital admission	Peak troponin I values will be compared among 3 groups with different coronary anatomy

Secondary Outcome Measures

Name	Time	Method
Peak troponin I value in acute coronary syndrome group	Within 48 hours after hospital admission	Peak troponin I values will be compared among group with coronary artery occlusion and group with spontaneous reperfusion
Admission troponin I value	Within 3 hours of cardiac arrest	Admission troponin I will be compared among 3 groups with different coronary anatomy

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia