Sensitive Troponin I in Out-of-hospital Cardiac Arrest

NCT02713048 | Completed

• 1 other identifier: TnI OHCA
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Acute Coronary Lesion; Stable Obstructive Coronary Disease; Non-obstructive Coronary Disease

Keywords

Cardiac arrest; Troponin I; coronary anatomy

Outcome Measures

Primary Outcomes (1)

• Peak Troponin I value

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

  Within 48 hours after hospital admission

Secondary Outcomes (2)

• Admission troponin I value

  Within 3 hours of cardiac arrest

• Peak troponin I value in acute coronary syndrome group

  Within 48 hours after hospital admission

Study Arms (3)

Acute coronary syndrome culprit coronary lesion

Other: Blood sample collection

Stable obstructive coronary artery disease

Other: Blood sample collection

Non-obstructive coronary artery disease

Other: Blood sample collection

Interventions

Blood sample collection OTHER

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

Acute coronary syndrome culprit coronary lesion; Non-obstructive coronary artery disease; Stable obstructive coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Comatose survivors after out-of-hospital cardiac arrest admitted to UMC Ljubljana

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (10)

• Spaulding CM, Joly LM, Rosenberg A, Monchi M, Weber SN, Dhainaut JF, Carli P. Immediate coronary angiography in survivors of out-of-hospital cardiac arrest. N Engl J Med. 1997 Jun 5;336(23):1629-33. doi: 10.1056/NEJM199706053362302.

  PMID: 9171064 BACKGROUND

• Dumas F, Cariou A, Manzo-Silberman S, Grimaldi D, Vivien B, Rosencher J, Empana JP, Carli P, Mira JP, Jouven X, Spaulding C. Immediate percutaneous coronary intervention is associated with better survival after out-of-hospital cardiac arrest: insights from the PROCAT (Parisian Region Out of hospital Cardiac ArresT) registry. Circ Cardiovasc Interv. 2010 Jun 1;3(3):200-7. doi: 10.1161/CIRCINTERVENTIONS.109.913665. Epub 2010 May 18.

  PMID: 20484098 BACKGROUND

• Noc M, Fajadet J, Lassen JF, Kala P, MacCarthy P, Olivecrona GK, Windecker S, Spaulding C; European Association for Percutaneous Cardiovascular Interventions (EAPCI); Stent for Life (SFL) Group. Invasive coronary treatment strategies for out-of-hospital cardiac arrest: a consensus statement from the European association for percutaneous cardiovascular interventions (EAPCI)/stent for life (SFL) groups. EuroIntervention. 2014 May;10(1):31-7. doi: 10.4244/EIJV10I1A7.

  PMID: 24832635 BACKGROUND

• Grubb NR, Fox KA, Cawood P. Resuscitation from out-of-hospital cardiac arrest: implications for cardiac enzyme estimation. Resuscitation. 1996 Nov;33(1):35-41. doi: 10.1016/s0300-9572(96)00971-9.

  PMID: 8959771 BACKGROUND

• Mullner M, Oschatz E, Sterz F, Pirich C, Exner M, Schorkhuber W, Laggner AN, Hirschl MM. The influence of chest compressions and external defibrillation on the release of creatine kinase-MB and cardiac troponin T in patients resuscitated from out-of-hospital cardiac arrest. Resuscitation. 1998 Aug;38(2):99-105. doi: 10.1016/s0300-9572(98)00087-2.

  PMID: 9863571 BACKGROUND

• Dumas F, Manzo-Silberman S, Fichet J, Mami Z, Zuber B, Vivien B, Chenevier-Gobeaux C, Varenne O, Empana JP, Pene F, Spaulding C, Cariou A. Can early cardiac troponin I measurement help to predict recent coronary occlusion in out-of-hospital cardiac arrest survivors? Crit Care Med. 2012 Jun;40(6):1777-84. doi: 10.1097/CCM.0b013e3182474d5e.

  PMID: 22488008 BACKGROUND

• Voicu S, Sideris G, Deye N, Dillinger JG, Logeart D, Broche C, Vivien B, Brun PY, Capan DD, Manzo-Silberman S, Megarbane B, Baud FJ, Henry P. Role of cardiac troponin in the diagnosis of acute myocardial infarction in comatose patients resuscitated from out-of-hospital cardiac arrest. Resuscitation. 2012 Apr;83(4):452-8. doi: 10.1016/j.resuscitation.2011.10.008. Epub 2011 Oct 29.

  PMID: 22037386 BACKGROUND

• Geri G, Mongardon N, Dumas F, Chenevier-Gobeaux C, Varenne O, Jouven X, Vivien B, Mira JP, Empana JP, Spaulding C, Cariou A. Diagnosis performance of high sensitivity troponin assay in out-of-hospital cardiac arrest patients. Int J Cardiol. 2013 Nov 30;169(6):449-54. doi: 10.1016/j.ijcard.2013.10.011. Epub 2013 Oct 16.

  PMID: 24157232 BACKGROUND

• Keller T, Zeller T, Peetz D, Tzikas S, Roth A, Czyz E, Bickel C, Baldus S, Warnholtz A, Frohlich M, Sinning CR, Eleftheriadis MS, Wild PS, Schnabel RB, Lubos E, Jachmann N, Genth-Zotz S, Post F, Nicaud V, Tiret L, Lackner KJ, Munzel TF, Blankenberg S. Sensitive troponin I assay in early diagnosis of acute myocardial infarction. N Engl J Med. 2009 Aug 27;361(9):868-77. doi: 10.1056/NEJMoa0903515.

  PMID: 19710485 BACKGROUND

• Berden J, Steblovnik K, Noc M. Mechanism and extent of myocardial injury associated with out-of-hospital cardiac arrest. Resuscitation. 2019 May;138:1-7. doi: 10.1016/j.resuscitation.2019.02.026. Epub 2019 Feb 28.

  PMID: 30826528 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marko Noc, MD, PhD

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 18, 2016
• Study Start: October 1, 2011
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)