Rapid Use of High-sensitive Cardiac Troponin I for ruling-in and Ruling-out of Acute Myocardial Infarction

NCT03634384 | Unknown DMC

• 1 other identifier: 54559
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Early rule-in or rule-out of myocardial infarction (MI) is essential in patients presenting to the Emergency Department with chest pain. Recently, the European Society of Cardiology has suggested an accelerated 0h/1h algorithm to rule-in or rule-out MI as a valid alternative to the standard 0h/3h approach. So far, the 0h/1h algorithm has only been validated for certain high-sensitive Troponin assays. Moreover, it is unknown if MI can be ruled-out by measuring hs-cTn already at 30 minutes (0h/30m) after presentation to the Emergency Department. This prospective cohort study aims to investigate, if a high-sensitive Troponin assay can rule-in or rule-out MI, when using a 0h/30m and a 0h/1h algorithm. Serial blood samples will be drawn from each patient and used for biomarker analysis. In addition, patients will be asked to complete a detailed questionnaire on chest pain characteristics.

Conditions

Myocardial Infarction; Chest Pain

Keywords

Myocardial Infarction; Chest Pain

Outcome Measures

Primary Outcomes (2)

• The diagnostic performance of the 0h/1h algorithm in terms of ruling-out MI.

  The negative predictive value of the 0h/1h algorithm

  1 hour after admission blood samples

• The diagnostic performance of the 0h/30m algorithm in terms of ruling-out MI.

  The negative predictive value of the 0h/30m algorithm

  30 minutes after admission blood samples

Secondary Outcomes (2)

• Overall diagnostic performance of the 0h/1h algorithm.

  1 hour after admission blood samples

• Overall diagnostic performance of the 0h/30m algorithm.

  30 minutes after admission blood samples

Study Arms (2)

Derivation cohort

We include eligible patients presenting with chest pain suggestive of myocardial infarction to the emergency department (see eligibility). For the primary study patients will be divided into two groups: 500 patients will serve as derivation cohort.

Validation cohort

We include eligible patients presenting with chest pain suggestive of myocardial infarction to the emergency department (see eligibility). For the primary study patients will be divided into two groups: 500 patients will serve as validation cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chest pain suggestive of myocardial infarction admitted to the Emergency Department

You may qualify if:

• Patients over 18 years of age
• Admitted to the Emergency Department
• Chest pain suggestive of myocardial infarction.

You may not qualify if:

• Patients \<18 years of age
• STEMI at admission
• Dialysis
• Pregnancy.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Randers Regional Hospital: collaborator

Study Sites (1)

Randers Regional Hospital

Randers, 8930, Denmark

RECRUITING

Related Publications (11)

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  PMID: 12147530 BACKGROUND

• Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

  PMID: 26320110 BACKGROUND

• Jaeger C, Wildi K, Twerenbold R, Reichlin T, Rubini Gimenez M, Neuhaus JD, Grimm K, Boeddinghaus J, Hillinger P, Nestelberger T, Singeisen H, Gugala M, Pretre G, Puelacher C, Wagener M, Honegger U, Schumacher C, Moreno Weidmann Z, Kreutzinger P, Krivoshei L, Freese M, Stelzig C, Dietsche S, Ernst S, Rentsch K, Osswald S, Mueller C. One-hour rule-in and rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I. Am Heart J. 2016 Jan;171(1):92-102.e1-5. doi: 10.1016/j.ahj.2015.07.022. Epub 2015 Jul 26.

  PMID: 26699605 BACKGROUND

• Reichlin T, Schindler C, Drexler B, Twerenbold R, Reiter M, Zellweger C, Moehring B, Ziller R, Hoeller R, Rubini Gimenez M, Haaf P, Potocki M, Wildi K, Balmelli C, Freese M, Stelzig C, Freidank H, Osswald S, Mueller C. One-hour rule-out and rule-in of acute myocardial infarction using high-sensitivity cardiac troponin T. Arch Intern Med. 2012 Sep 10;172(16):1211-8. doi: 10.1001/archinternmed.2012.3698.

  PMID: 22892889 BACKGROUND

• Reichlin T, Twerenbold R, Wildi K, Gimenez MR, Bergsma N, Haaf P, Druey S, Puelacher C, Moehring B, Freese M, Stelzig C, Krivoshei L, Hillinger P, Jager C, Herrmann T, Kreutzinger P, Radosavac M, Weidmann ZM, Pershyna K, Honegger U, Wagener M, Vuillomenet T, Campodarve I, Bingisser R, Miro O, Rentsch K, Bassetti S, Osswald S, Mueller C. Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay. CMAJ. 2015 May 19;187(8):E243-E252. doi: 10.1503/cmaj.141349. Epub 2015 Apr 13.

  PMID: 25869867 BACKGROUND

• Mueller C, Giannitsis E, Christ M, Ordonez-Llanos J, deFilippi C, McCord J, Body R, Panteghini M, Jernberg T, Plebani M, Verschuren F, French J, Christenson R, Weiser S, Bendig G, Dilba P, Lindahl B; TRAPID-AMI Investigators. Multicenter Evaluation of a 0-Hour/1-Hour Algorithm in the Diagnosis of Myocardial Infarction With High-Sensitivity Cardiac Troponin T. Ann Emerg Med. 2016 Jul;68(1):76-87.e4. doi: 10.1016/j.annemergmed.2015.11.013. Epub 2016 Jan 12.

  PMID: 26794254 BACKGROUND

• Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. No abstract available.

  PMID: 25249586 BACKGROUND

• Liebetrau C, Mollmann H, Nef H, Szardien S, Rixe J, Troidl C, Willmer M, Hoffmann J, Weber M, Rolf A, Hamm C. Release kinetics of cardiac biomarkers in patients undergoing transcoronary ablation of septal hypertrophy. Clin Chem. 2012 Jun;58(6):1049-54. doi: 10.1373/clinchem.2011.178129. Epub 2012 Apr 13.

  PMID: 22504118 BACKGROUND

• Andersen CF, Bang C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. External validation of a high-sensitive troponin I algorithm for rapid evaluation of acute myocardial infarction in a Danish cohort. Eur Heart J Acute Cardiovasc Care. 2021 Dec 6;10(9):1056-1064. doi: 10.1093/ehjacc/zuab062.

  PMID: 34423355 DERIVED

• Andersen CF, Bang C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. Single troponin measurement to rule-out acute myocardial infarction in early presenters. Int J Cardiol. 2021 Oct 15;341:15-21. doi: 10.1016/j.ijcard.2021.08.005. Epub 2021 Aug 13.

  PMID: 34391791 DERIVED

• Bang C, Hansen C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. Rapid use of high-sensitive cardiac troponin I for ruling-in and ruling-out of acute myocardial infarction (RACING-MI): study protocol. Open Heart. 2019 Apr 3;6(1):e000995. doi: 10.1136/openhrt-2018-000995. eCollection 2019.

  PMID: 31168384 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lithium-Heparin, Serum

MeSH Terms

Conditions

Myocardial Infarction; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bo Løfgren, Professor, MD, PhD

  Randers Regional Hospital

  STUDY DIRECTOR

• Camilla Bang, MD

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

• Camilla Hansen, MD

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Løfgren, Professor, MD, PhD

CONTACT

+4578420000; bl@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, FESC

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 16, 2018
• Study Start: November 21, 2016
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2020
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)