AzTrials
AzTrials

Myocardial InfarctionAPACENCT00470587

Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study

An observational study of Myocardial Infarction and Angina, Unstable, run by University Hospital, Basel, Switzerland at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The triage of patients with suspected acute coronary syndrome in the emergency room is a time-consuming diagnostic challenge. Therefore high sensitive early markers for myocardial damage are needed for more rapidly rule out of acute myocardial infarction (AMI) - especially for the first 3 to 4 hours after onset of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction, Angina, Unstable
How many people
10,000 participants
Where
13 sitesin 5 countries
Study dates
Apr 2006to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients presenting to the emergency department with typical angina pectoris or other thoracic sensations at rest or minor exertion that are suspected to be caused by myocardial ischemia. Onset of symptoms within the last 12 hours prior to presentation.

Who may be able to join

  • Patients presenting to the emergency department
  • Typical angina pectoris or other thoracic sensations that are suspected to be caused by myocardial ischemia
  • Symptoms at rest or minor exertion
  • Onset of symptoms within the last 12 hours prior to presentation
  • Written informed consent

Who cannot join

  • Age < 18 years
  • Cardiogenic shock
  • Terminal kidney disease requiring regular dialysis

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

Switzerland7 sites
  • University Hospital of Basel

    Basel, 4031

  • Kantonsspital Baselland, Standort Bruderholz

    Bottmingen

  • Kantonsspital Baselland, Standort Liestal

    Liestal

  • Klinik St. Anna

    Lucerne

  • Kantonsspital Olten

    Olten

  • Spital Limmattal

    Schlieren

  • Universitätsspital Zürich

    Zurich

Other trials in Switzerland

Spain3 sites
  • Hospital Clinic of Barcelona

    Barcelona, 08036

  • Hospital del Mar

    Barcelona

  • Hospital Clinico San Carlos

    Madrid

Other trials in Spain

Czechia1 site
  • Masaryk University Brno

    Brno

Other trials in Czechia

Italy1 site
  • Emergency Department San Martino Hospital

    Genova

Other trials in Italy

Poland1 site
  • Medical University of Silesia

    Zabrze

Other trials in Poland

About this study

The triage of patients with suspected acute coronary syndrome in the emergency room is a time-consuming diagnostic challenge. Therefore high sensitive early markers for myocardial damage are needed for more rapidly rule out of acute myocardial infarction (AMI) - especially for the first 3 to 4 hours after onset of chest pain in AMI ("troponin-blind" period).

Therefore we test the hypothesis that the use meticulous patient history and novel cardiac markers can provide a faster detection or exclusion of AMI in patients presenting with acute chest pain to the emergency department.

The prospective cohort study is designed to enrol patients presenting with acute chest pain at rest within the last 12 hours to the emergency department. Several blood samples for detection of the new markers will be drawn and compared with the gold standard for the diagnosis of AMI (high-sensitivity cardiac troponin T). All patients will be contacted by telephone at 3, 12, 24 and 60 months to determine functional status, major adverse cardiac events (death, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention), and the results of cardiac examination (stress test, coronary angiography) if performed.

Read the detailed description

Background: The triage of patients with suspected acute coronary syndrome in the emergency room is a time-consuming diagnostic challenge. Triage and management of patients with low probability of coronary artery disease often cause excessive hospital costs. Therefore high sensitive early markers for myocardial damage are needed for more rapidly rule out of acute myocardial infarction (AMI).

Cardiac troponins (T and I) are currently the gold standard for definitive AMI diagnosis due to their high sensitivity and specificity for detection of myocardial cell injury. Unfortunately, troponin is undetectable by current assays in peripheral blood within 3 to 4 hours after onset of chest pain in AMI ("troponin-blind" period).

New cardiac markers such as the novel high-sensitive troponin I/T, ischemia modified albumin and placental growth factor have demonstrated certain advantages compared to troponin such as high negative predictive value for AMI, earlier verifiability in peripheral blood and possible value as independent risk marker. However, clinical evaluation in a large cohort of unselected patients presenting to an emergency department is still lacking.

Aim: To test the hypothesis that the use meticulous patient history and novel cardiac markers (including high-sensitive troponin I/T, myeloperoxidase, ischemia modified albumin, placental growth factor) can provide a faster detection or exclusion of AMI in patients presenting with acute chest pain to the emergency department.

Patients and Methods: The prospective cohort study is designed to enrol unselected patients presenting with acute chest pain at rest within the last 12 hours to the emergency department. Several blood samples for detection of the new markers will be drawn (baseline, 1, 2, 3 and 6 hours) and compared with the gold standard for the diagnosis of AMI (high-sensitivity cardiac troponin T). Timing and treatment of patients are left to the discretion of the attending physician and will be performed according to the standard house routine of the hospital. All patients will be contacted by telephone at 6, 12, 24 and 60 months to determine functional status, major adverse cardiac events (death, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention), and the results of cardiac examination (stress test, coronary angiography) if performed.

Expected results: It is our hypothesis that the use meticulous patient history and novel cardiac markers can improve the detection of AMI by providing an early diagnosis for AMI with a high negative predictive value within the "troponin-blind" period.

Significance: The earlier detection of myocardial necrosis in peripheral blood could help to rule out AMI more rapidly. In addition it will allow a more rapid diagnosis and appropriate therapy of AMI. This can lead to a significant improvement in patient management and a reduction of in-hospital costs.

Keywords
chest pain, myocardial infarction, unstable angina
Medical subject headings
Myocardial Infarction, Angina, Unstable, Chest Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic utility of various biomarkers, detailed patient's history and examination as well as ECG findings for the early diagnosis of acute myocardial infarction

    Measured: at admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2007 (estimated)
  2. Study startApr 2006
  3. Primary completion2 Mar 2025
  4. Study completionDec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00470587
Sponsor's protocol ID
APACE
Acronym
APACE
Status last verified
Dec 2025
First submitted
7 May 2007
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Odermatt R, Koechlin L, Lopez-Ayala P, Kaplan E, Recuenco LH, Hure G, Bima P, Crisanti L, Wildi K, Miro O, Christ M, Keller DI, Martin-Sanchez JF, Morawiec B, Geigy N, Mahfoud F, Biefer HRC, Dzemali O, Boeddinghaus J, Strebel I, Mueller C; APACE Investigators. Cardiac Myosin-Binding Protein C for Diagnosis of Myocardial Infarction in Patients With Prior Coronary Artery Bypass Grafting. J Am Heart Assoc. 2026 Oct 10:e049244. doi: 10.1161/JAHA.126.049244. Online ahead of print.

    PubMed 42858040
  • Koechlin L, Boeddinghaus J, Lopez-Ayala P, Jacobsen G, McCord J, Heimbach B, Nestelberger T, Wildi K, Kaplan E, Gualandro DM, Hure G, Miro O, Christ M, Martin-Sanchez FJ, Rodriguez Cetina Biefer H, Dzemali O, Mahfoud F, Mueller C; APACE investigators. Direct Comparison of the 0/1h- and 0/2h-Algorithms in Patients With Prior Coronary Artery Bypass Grafting. J Am Heart Assoc. 2026 Aug 20:e046718. doi: 10.1161/JAHA.125.046718. Online ahead of print.

    PubMed 42622139
  • Champetier A, Lopez-Ayala P, Reich C, Boeddinghaus J, Cattin P, Koechlin L, Miro O, Christ M, Keller DI, Martin-Sanchez FJ, Morawiec B, Parenica J, Kaplan E, Bima P, Recuenco LH, Hure G, Herzka D, Wildi K, Crisanti L, Durak K, Schaffer JS, Zimmermann T, Mahfoud F, Lindahl B, Giannitsis E, Strebel I, Mueller C; APACE; TRAPID-AMI Investigatorsn; TRAPID-AMI Investigators. Machine learning for diagnosing non-ST-segment elevation myocardial infarction: a derivation and validation study. EClinicalMedicine. 2026 Jul 9;97:104055. doi: 10.1016/j.eclinm.2026.104055. eCollection 2026 Jul.

    PubMed 42473534
  • Durak K, Lopez-Ayala P, Koechlin L, Boeddinghaus J, De Vita F, Kaplan E, Herraiz-Recuenco L, Miro O, Christ M, Keller DI, Martin-Sanchez JF, Morawiec B, Parenica J, Hure G, Dinkel O, Wildi K, Bima P, Glaeser J, Spagnuolo C, Mahfoud F, Strebel I, Mueller C; APACE investigators. Alternative Rule-Out Cutoffs for a Novel High-Sensitivity Cardiac Troponin I Assay in Patients With Suspected Myocardial Infarction. J Am Heart Assoc. 2026 Apr 21;15(8):e045517. doi: 10.1161/JAHA.125.045517. Epub 2026 Apr 16.

    PubMed 41988955
  • Koechlin L, Lopez-Ayala P, Thurston AJF, Tew YY, O'Brien R, Gray A, Bima P, Kaplan E, Miro O, Christ M, Keller DI, Martin-Sanchez JF, Morawiec B, Parenica J, Herraiz Recuenco L, Hure G, Wildi K, Crisanti L, Spagnuolo C, Glaeser J, Caubergh C, Rentsch K, Slankamenac K, Rodriguez Cetina Biefer H, Dzemali O, Strebel I, Mahfoud F, Mills NL, Boeddinghaus J, Mueller C; APACE and POC-ET Investigators. High-Sensitivity Cardiac Troponin T-gen6 Assay in Suspected Myocardial Infarction: Diagnostic Accuracy, Cutoffs, and Clinical Implications. J Am Coll Cardiol. 2026 May 5;87(17):2236-2257. doi: 10.1016/j.jacc.2025.12.052. Epub 2026 Mar 25.

    PubMed 41879583
  • Lopez-Ayala P, Boeddinghaus J, Koechlin L, Bima P, Glaeser J, Spagnuolo CC, Crisanti L, Miro O, Martin-Sanchez FJ, Christ M, Wildi K, Piazza S, Nestelberger T, Gimenez MR, Gehrke J, Formambuh J, Kaplan E, Hure G, Breidthardt T, Giannitsis E, Lindahl B, Marber M, Mahfoud F, Strebel I, Mueller C; APACE and TRAPID-AMI investigators. Incremental Value of Cardiac Myosin-Binding Protein C for the Early Diagnosis of Acute Myocardial Infarction. J Am Coll Cardiol. 2025 Dec 23;86(25):2616-2632. doi: 10.1016/j.jacc.2025.09.008. Epub 2025 Nov 12.

    PubMed 41222525
  • Dugar F, Lopez-Ayala P, Koechlin L, Bima P, Glaeser J, Spagnuolo C, Crisanti L, Wick C, Wildi K, Kaplan E, Strebel I, Miro O, Martin-Sanchez FJ, Christ M, Morawiec B, Gimenez MR, Nestelberger T, Boeddinghaus J, Mueller C; APACE investigators. Diagnostic and prognostic utility of endocan in suspected myocardial infarction: an international cohort study. Clin Chim Acta. 2026 Jan 1;578:120510. doi: 10.1016/j.cca.2025.120510. Epub 2025 Jul 25.

    PubMed 40716696
  • Wildi K, Gimenez MR, Boeddinghaus J, Nestelberger T, Lopez-Ayala P, Koechlin L, Gerstenberger M, Carter N, Bima P, Glaeser J, Spagnuolo C, Miro O, Martin-Sanchez FJ, Christ M, Keller DI, Gualandro DM, Kawecki D, Rentsch K, Mahfoud F, Mueller C; APACE Investigators dagger. Possible Misdiagnosis of Myocardial Infarction Using Regulatory-Approved and Close-to-Bioequivalent Upper Limits of Normal for Cardiac Troponin. J Am Heart Assoc. 2025 May 20;14(10):e040468. doi: 10.1161/JAHA.124.040468. Epub 2025 May 13.

    PubMed 40357766
  • Koechlin L, Boeddinghaus J, Lopez-Ayala P, Reber C, Nestelberger T, Wildi K, Spagnuolo CC, Strebel I, Glaeser J, Bima P, Crisanti L, Herraiz-Recuenco L, Dubach E, Miro O, Martin-Sanchez FJ, Kawecki D, Keller DI, Christ M, Buser A, Gimenez MR, Storvold GL, Broughton MN, Omland T, Lyngbakken MN, Rosjo H, Mueller C; APACE Investigators. Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay. J Am Coll Cardiol. 2024 Aug 20;84(8):726-740. doi: 10.1016/j.jacc.2024.05.056.

    PubMed 39142727
  • Albus M, Zimmermann T, Median D, Rumora K, Isayeva G, Amrein M, Schaefer I, Walter J, Michel E, Hure G, Strebel I, Caobelli F, Haaf P, Frey SM, Mueller C, Zellweger MJ. Combining anatomical and biochemical markers in the detection and risk stratification of coronary artery disease. Eur Heart J Cardiovasc Imaging. 2024 Aug 26;25(9):1197-1205. doi: 10.1093/ehjci/jeae093.

    PubMed 38591997
  • Boeddinghaus J, Doudesis D, Lopez-Ayala P, Lee KK, Koechlin L, Wildi K, Nestelberger T, Borer R, Miro O, Martin-Sanchez FJ, Strebel I, Rubini Gimenez M, Keller DI, Christ M, Bularga A, Li Z, Ferry AV, Tuck C, Anand A, Gray A, Mills NL, Mueller C; CoDE-ACS and APACE Investigators. Machine Learning for Myocardial Infarction Compared With Guideline-Recommended Diagnostic Pathways. Circulation. 2024 Apr 2;149(14):1090-1101. doi: 10.1161/CIRCULATIONAHA.123.066917. Epub 2024 Feb 12.

    PubMed 38344871
  • Koechlin L, Boeddinghaus J, Lopez-Ayala P, Wildi K, Nestelberger T, Wussler D, Guzman Tacla CA, Holder T, Muench-Gerber T, Glaeser J, Sanchez AY, Miro O, Martin-Sanchez FJ, Kawecki D, Buergler F, Buser A, Hure G, Gimenez MR, Keller DI, Christ M, Mueller C; APACE investigators. External validation of the 0/1h-algorithm and derivation of a 0/2h-algorithm using a new point-of-care Hs-cTnI assay. Am Heart J. 2024 Feb;268:104-113. doi: 10.1016/j.ahj.2023.11.014. Epub 2023 Dec 1.

    PubMed 38042459
  • Bima P, Lopez-Ayala P, Koechlin L, Boeddinghaus J, Nestelberger T, Okamura B, Muench-Gerber TS, Sanzone A, Skolozubova D, Djurdjevic D, Rubini Gimenez M, Wildi K, Miro O, Martinez-Nadal G, Martin-Sanchez FJ, Christ M, Keller D, Lindahl B, Giannitsis E, Mueller C; APACE and TRAPID-AMI Investigators. Chest Pain in Cancer Patients: Prevalence of Myocardial Infarction and Performance of High-Sensitivity Cardiac Troponins. JACC CardioOncol. 2023 Aug 26;5(5):591-609. doi: 10.1016/j.jaccao.2023.08.001. eCollection 2023 Oct.

    PubMed 37969646
  • Yufera-Sanchez A, Lopez-Ayala P, Nestelberger T, Wildi K, Boeddinghaus J, Koechlin L, Rubini Gimenez M, Sakiz H, Bima P, Miro O, Martin-Sanchez FJ, Christ M, Keller DI, Gualandro DM, Kawecki D, Rentsch K, Buser A, Mueller C; APACE Investigators. Combining glucose and high-sensitivity cardiac troponin in the early diagnosis of acute myocardial infarction. Sci Rep. 2023 Sep 5;13(1):14598. doi: 10.1038/s41598-023-37093-1.

    PubMed 37670005
  • Fernandez-Cisnal A, Lopez-Ayala P, Valero E, Koechlin L, Catarrala A, Boeddinghaus J, Noceda J, Nestelberger T, Miro O, Julio N, Mueller C, Sanchis J. Derivation and external validation of machine-learning models for risk stratification in chest pain with normal troponin. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):743-752. doi: 10.1093/ehjacc/zuad089.

    PubMed 37531633

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction and Angina, Unstable, run by University Hospital, Basel, Switzerland at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Switzerland, Spain, Czechia, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic utility of various biomarkers, detailed patient's history and examination as well as ECG findings for the early diagnosis of acute myocardial infarction (time frame: at admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00470587, which also lists 85 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in