Sensitive Troponin I in Out-of-hospital Cardiac Arrest

NCT ID: NCT02713048

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute coronary syndrome culprit coronary lesion

Blood sample collection

Intervention Type OTHER

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

Stable obstructive coronary artery disease

Blood sample collection

Intervention Type OTHER

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

Non-obstructive coronary artery disease

Blood sample collection

Intervention Type OTHER

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

Interventions

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Blood sample collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Marko Noc

Marko Noc, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type BACKGROUND
PMID: 9171064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20484098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24832635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8959771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9863571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22488008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22037386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24157232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19710485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30826528 (View on PubMed)

Other Identifiers

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TnI OHCA

Identifier Type: -

Identifier Source: org_study_id

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