NCT02355457

Brief Summary

The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2013Dec 2027

Study Start

First participant enrolled

July 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

14.4 years

First QC Date

January 30, 2015

Last Update Submit

May 10, 2024

Conditions

Acute Coronary SyndromeMyocardial InfarctionChest Pain

Keywords

troponinmyocardial infarctionacsAMIbiomarkerBACChigh-sensitivity

Outcome Measures

Primary Outcomes (1)

  • Acute myocardial infarction as index event

    The primary endpoint of the study is acute myocardial infarction

    Months

Secondary Outcomes (1)

  • AMI, Mortality, heart failure and quality of life

    Years

Study Arms (1)

Suspected acute myocardial infarction

Patients with recent onset symptoms suggesting acute myocardial infarction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients presenting with suspected myocardial infarction in the emergency department or the chest pain unit of the University Hospital Hamburg-Eppendorf.

You may qualify if:

  • Symptoms suggestive of acute myocardial infarction
  • Ability to provide written informed consent in accordance with Good epidemiological Practice and local legislation
  • Individuals at least 18 years old

You may not qualify if:

  • \- Insufficient knowledge of the German language (able to understand and write the German language)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, University Heart Center Hamburg

Hamburg, 20246, Germany

RECRUITING

Related Publications (25)

  • Neumann JT, Sorensen NA, Schwemer T, Ojeda F, Bourry R, Sciacca V, Schaefer S, Waldeyer C, Sinning C, Renne T, Than M, Parsonage W, Wildi K, Makarova N, Schnabel RB, Landmesser U, Mueller C, Cullen L, Greenslade J, Zeller T, Blankenberg S, Karakas M, Westermann D. Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I 1-Hour Algorithm. JAMA Cardiol. 2016 Jul 1;1(4):397-404. doi: 10.1001/jamacardio.2016.0695.

    PMID: 27438315RESULT

  • Neumann JT, Sorensen NA, Ojeda F, Schwemer T, Lehmacher J, Gonner S, Jarsetz N, Keller T, Schaefer S, Renne T, Landmesser U, Clemmensen P, Makarova N, Schnabel RB, Zeller T, Karakas M, Pickering JW, Than M, Parsonage W, Greenslade J, Cullen L, Westermann D, Blankenberg S. Immediate Rule-Out of Acute Myocardial Infarction Using Electrocardiogram and Baseline High-Sensitivity Troponin I. Clin Chem. 2017 Jan;63(1):394-402. doi: 10.1373/clinchem.2016.262659. Epub 2016 Nov 30.

    PMID: 27903616RESULT

  • Haller PM, Schock A, Kellner C, Lehmacher J, Toprak B, Hartikainen TS, Kiss KM, Alhaou G, Peifer K, Twerenbold R, Zeller T, Westermann D, Neumann JT, Sorensen NA. Bedside echocardiography in patients with suspected acute myocardial infarction without ST elevation. Clin Res Cardiol. 2025 Aug 19. doi: 10.1007/s00392-025-02724-2. Online ahead of print.

    PMID: 40828180DERIVED

  • Thiebetaen N, Pickering JW, Kellner C, Haller PM, Lehmacher J, Toprak B, Twerenbold R, Sorensen NA, Pemberton C, Troughton R, Richards AM, Sharif S, Worster A, Than M, Kavsak PA, Neumann JT. A Common Algorithm for Cardiac Troponin to Rule Out and Rule in Acute Myocardial Infarction. Can J Cardiol. 2025 Jul;41(7):1351-1360. doi: 10.1016/j.cjca.2025.02.029. Epub 2025 Feb 26.

    PMID: 40021054DERIVED

  • Haller PM, Kellner C, Sorensen NA, Lehmacher J, Toprak B, Schock A, Hartikainen TS, Twerenbold R, Zeller T, Westermann D, Neumann JT. Long-term outcome of patients presenting with myocardial injury or myocardial infarction. Clin Res Cardiol. 2025 Jun;114(6):700-708. doi: 10.1007/s00392-023-02334-w. Epub 2023 Nov 20.

    PMID: 37982865DERIVED

  • Haller PM, Sorensen NA, Hartikainen TS, Gossling A, Lehmacher J, Toprak B, Twerenbold R, Richter J, Banko T, Korschid S, Schmidt J, Keller T, Zeller T, Blankenberg S, Westermann D, Neumann JT. Rising and Falling High-Sensitivity Cardiac Troponin in Diagnostic Algorithms for Patients With Suspected Myocardial Infarction. J Am Heart Assoc. 2023 May 16;12(10):e027166. doi: 10.1161/JAHA.122.027166. Epub 2023 May 9.

    PMID: 37158171DERIVED

  • Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.

    PMID: 37131096DERIVED

  • von Haehling S, Muller-Hennessen M, Garfias-Veitl T, Gossling A, Neumann JT, Sorensen NA, Haller PM, Hartikainen T, Vollert JO, Mockel M, Blankenberg S, Westermann D, Giannitsis E. Role of Copeptin and hs-cTnT to Discriminate AHF from Uncomplicated NSTE-ACS with Baseline Elevated hs-cTnT-A Derivation and External Validation Study. Cells. 2023 Mar 31;12(7):1062. doi: 10.3390/cells12071062.

    PMID: 37048135DERIVED

  • Lehmacher J, Neumann JT, Sorensen NA, Gossling A, Schmidt SE, Zeller T, Blankenberg S, Westermann D, Clemmensen PM. Diagnostic performance of a device for acoustic heart sound analysis in patients with suspected myocardial infarction. Open Heart. 2023 Mar;10(1):e002090. doi: 10.1136/openhrt-2022-002090.

    PMID: 36858602DERIVED

  • Hartikainen TS, Gossling A, Sorensen NA, Lehmacher J, Neumann JT, Blankenberg S, Westermann D. Prognostic Implications of a Second Peak of High-Sensitivity Troponin T After Myocardial Infarction. Front Cardiovasc Med. 2022 Jan 31;8:780198. doi: 10.3389/fcvm.2021.780198. eCollection 2021.

    PMID: 35174220DERIVED

  • Neumann JT, Weimann J, Sorensen NA, Hartikainen TS, Haller PM, Lehmacher J, Brocks C, Tenhaeff S, Karakas M, Renne T, Blankenberg S, Zeller T, Westermann D. A Biomarker Model to Distinguish Types of Myocardial Infarction and Injury. J Am Coll Cardiol. 2021 Aug 24;78(8):781-790. doi: 10.1016/j.jacc.2021.06.027.

    PMID: 34412811DERIVED

  • Haller PM, Neumann JT, Sorensen NA, Hartikainen TS, Gossling A, Lehmacher J, Keller T, Zeller T, Blankenberg S, Westermann D. The association of anaemia and high-sensitivity cardiac troponin and its effect on diagnosing myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1187-1196. doi: 10.1093/ehjacc/zuab066.

    PMID: 34350455DERIVED

  • Sorensen NA, Gossling A, Neumann JT, Hartikainen TS, Haller PM, Scharlemann L, Lehmacher J, Ziegler A, Blankenberg S, Zeller T, Nordholt G, Renne T, Westermann D. Diagnostic Validation of a High-Sensitivity Cardiac Troponin I Assay. Clin Chem. 2021 Sep 1;67(9):1230-1239. doi: 10.1093/clinchem/hvab070.

    PMID: 34254126DERIVED

  • Sorensen NA, Neumann JT, Ojeda F, Renne T, Karakas M, Blankenberg S, Westermann D, Zeller T. Differences in measurement of high-sensitivity troponin in an on-demand and batch-wise setting. Eur Heart J Acute Cardiovasc Care. 2021 May 11;10(3):302-309. doi: 10.1177/2048872620924198. Epub 2020 Jul 23.

    PMID: 32700543DERIVED

  • Neumann JT, Sorensen NA, Zeller T, Magaret CA, Barnes G, Rhyne RF, Peters C, Gossling A, Hartikainen TS, Haller PM, Lehmacher J, Schafer S, Januzzi JL, Westermann D. Application of a machine learning-driven, multibiomarker panel for prediction of incident cardiovascular events in patients with suspected myocardial infarction. Biomark Med. 2020 Jun;14(9):775-784. doi: 10.2217/bmm-2019-0584. Epub 2020 May 28.

    PMID: 32462911DERIVED

  • Haller PM, Boeddinghaus J, Neumann JT, Sorensen NA, Hartikainen TS, Gossling A, Nestelberger T, Twerenbold R, Lehmacher J, Keller T, Zeller T, Blankenberg S, Mueller C, Westermann D. Performance of the ESC 0/1-h and 0/3-h Algorithm for the Rapid Identification of Myocardial Infarction Without ST-Elevation in Patients With Diabetes. Diabetes Care. 2020 Feb;43(2):460-467. doi: 10.2337/dc19-1327. Epub 2019 Dec 16.

    PMID: 31843947DERIVED

  • Neumann JT, Twerenbold R, Ojeda F, Sorensen NA, Chapman AR, Shah ASV, Anand A, Boeddinghaus J, Nestelberger T, Badertscher P, Mokhtari A, Pickering JW, Troughton RW, Greenslade J, Parsonage W, Mueller-Hennessen M, Gori T, Jernberg T, Morris N, Liebetrau C, Hamm C, Katus HA, Munzel T, Landmesser U, Salomaa V, Iacoviello L, Ferrario MM, Giampaoli S, Kee F, Thorand B, Peters A, Borchini R, Jorgensen T, Soderberg S, Sans S, Tunstall-Pedoe H, Kuulasmaa K, Renne T, Lackner KJ, Worster A, Body R, Ekelund U, Kavsak PA, Keller T, Lindahl B, Wild P, Giannitsis E, Than M, Cullen LA, Mills NL, Mueller C, Zeller T, Westermann D, Blankenberg S; COMPASS-MI Study Group. Application of High-Sensitivity Troponin in Suspected Myocardial Infarction. N Engl J Med. 2019 Jun 27;380(26):2529-2540. doi: 10.1056/NEJMoa1803377.

    PMID: 31242362DERIVED

  • Sorensen NA, Nikorowitsch J, Neumann JT, Rubsamen N, Gossling A, Hartikainen TS, Blankenberg S, Westermann D, Zeller T, Karakas M. Predictive value of soluble urokinase-type plasminogen activator receptor for mortality in patients with suspected myocardial infarction. Clin Res Cardiol. 2019 Dec;108(12):1386-1393. doi: 10.1007/s00392-019-01475-1. Epub 2019 Apr 16.

    PMID: 30989318DERIVED

  • Neumann JT, Sorensen NA, Rubsamen N, Ojeda F, Schock A, Seddighizadeh P, Zeller T, Westermann D, Blankenberg S. Evaluation of a new ultra-sensitivity troponin I assay in patients with suspected myocardial infarction. Int J Cardiol. 2019 May 15;283:35-40. doi: 10.1016/j.ijcard.2018.12.001. Epub 2018 Dec 5.

    PMID: 30528623DERIVED

  • Boeddinghaus J, Nestelberger T, Twerenbold R, Neumann JT, Lindahl B, Giannitsis E, Sorensen NA, Badertscher P, Jann JE, Wussler D, Puelacher C, Rubini Gimenez M, Wildi K, Strebel I, Du Fay de Lavallaz J, Selman F, Sabti Z, Kozhuharov N, Potlukova E, Rentsch K, Miro O, Martin-Sanchez FJ, Morawiec B, Parenica J, Lohrmann J, Kloos W, Buser A, Geigy N, Keller DI, Osswald S, Reichlin T, Westermann D, Blankenberg S, Mueller C; APACE, BACC, and TRAPID-AMI Investigators. Impact of age on the performance of the ESC 0/1h-algorithms for early diagnosis of myocardial infarction. Eur Heart J. 2018 Nov 7;39(42):3780-3794. doi: 10.1093/eurheartj/ehy514.

    PMID: 30169752DERIVED

  • Kavsak PA, Neumann JT, Cullen L, Than M, Shortt C, Greenslade JH, Pickering JW, Ojeda F, Ma J, Clayton N, Sherbino J, Hill SA, McQueen M, Westermann D, Sorensen NA, Parsonage WA, Griffith L, Mehta SR, Devereaux PJ, Richards M, Troughton R, Pemberton C, Aldous S, Blankenberg S, Worster A. Clinical chemistry score versus high-sensitivity cardiac troponin I and T tests alone to identify patients at low or high risk for myocardial infarction or death at presentation to the emergency department. CMAJ. 2018 Aug 20;190(33):E974-E984. doi: 10.1503/cmaj.180144.

    PMID: 30127037DERIVED

  • Sorensen NA, Neumann JT, Ojeda F, Schafer S, Magnussen C, Keller T, Lackner KJ, Zeller T, Karakas M, Munzel T, Blankenberg S, Westermann D, Schnabel RB. Relations of Sex to Diagnosis and Outcomes in Acute Coronary Syndrome. J Am Heart Assoc. 2018 Mar 10;7(6):e007297. doi: 10.1161/JAHA.117.007297.

    PMID: 29525782DERIVED

  • Neumann JT, Sorensen NA, Rubsamen N, Ojeda F, Renne T, Qaderi V, Teltrop E, Kramer S, Quantius L, Zeller T, Karakas M, Blankenberg S, Westermann D. Discrimination of patients with type 2 myocardial infarction. Eur Heart J. 2017 Dec 14;38(47):3514-3520. doi: 10.1093/eurheartj/ehx457.

    PMID: 29020401DERIVED

  • Neumann JT, Sorensen NA, Ojeda F, Renne T, Schnabel RB, Zeller T, Karakas M, Blankenberg S, Westermann D. Early diagnosis of acute myocardial infarction using high-sensitivity troponin I. PLoS One. 2017 Mar 23;12(3):e0174288. doi: 10.1371/journal.pone.0174288. eCollection 2017.

    PMID: 28333976DERIVED

  • Sorensen NA, Neumann JT, Ojeda F, Schwemer T, Renne T, Schnabel RB, Zeller T, Karakas M, Blankenberg S, Westermann D. Challenging the 99th percentile: A lower troponin cutoff leads to low mortality of chest pain patients. Int J Cardiol. 2017 Apr 1;232:289-293. doi: 10.1016/j.ijcard.2016.12.167. Epub 2016 Dec 27.

    PMID: 28087181DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, white blood cells.

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionChest Pain

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Johannes Neumann, MD

    UHZ

    PRINCIPAL INVESTIGATOR

  • Nils Sörensen, MD

    UHZ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes T Neumann, MD

CONTACT

0049407410j.neumann@uke.de

Nils Sörensen, MD

CONTACT

0049407410n.soerensen@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

July 1, 2013

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations

DE(1)