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- Ensayo clínico NCT02713048
Sensitive Troponin I in Out-of-hospital Cardiac Arrest
Sensitive Troponin I and Coronary Anatomy in Patients With 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ljubljana, Eslovenia, 1000
- University Medical Centre Ljubljana
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Acute coronary syndrome culprit coronary lesion
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Eight blood samples in each patient within 48 hours to perform Troponin I measurement.
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Stable obstructive coronary artery disease
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Eight blood samples in each patient within 48 hours to perform Troponin I measurement.
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Non-obstructive coronary artery disease
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Eight blood samples in each patient within 48 hours to perform Troponin I measurement.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Peak Troponin I value
Periodo de tiempo: Within 48 hours after hospital admission
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Peak troponin I values will be compared among 3 groups with different coronary anatomy
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Within 48 hours after hospital admission
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Admission troponin I value
Periodo de tiempo: Within 3 hours of cardiac arrest
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Admission troponin I will be compared among 3 groups with different coronary anatomy
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Within 3 hours of cardiac arrest
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Peak troponin I value in acute coronary syndrome group
Periodo de tiempo: Within 48 hours after hospital admission
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Peak troponin I values will be compared among group with coronary artery occlusion and group with spontaneous reperfusion
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Within 48 hours after hospital admission
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
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Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TnI OHCA
Plan de datos de participantes individuales (IPD)
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