Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study

Last updated: July 8, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Cardiovascular Disease

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT00470587
APACE
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients presenting to the emergency department

  • Typical angina pectoris or other thoracic sensations that are suspected to be causedby myocardial ischemia

  • Symptoms at rest or minor exertion

  • Onset of symptoms within the last 12 hours prior to presentation

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Age < 18 years

  • Cardiogenic shock

  • Terminal kidney disease requiring regular dialysis

Study Design

Total Participants: 10000
Study Start date:
April 01, 2006
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Hospital Erasme, Université Libre de Bruxelles

    Brussels,
    Belgium

    Site Not Available

  • Masaryk University Brno

    Brno,
    Czechia

    Active - Recruiting

  • Emergency Department San Martino Hospital

    Genova,
    Italy

    Active - Recruiting

  • Medical University of Silesia

    Zabrze,
    Poland

    Active - Recruiting

  • Hospital Clinic of Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • University Hospital of Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Kantonsspital Baselland, Standort Bruderholz

    Bottmingen,
    Switzerland

    Completed

  • University Hospital Bruderholz

    Bruderholz,
    Switzerland

    Site Not Available

  • Kantonsspital Baselland, Standort Liestal

    Liestal,
    Switzerland

    Active - Recruiting

  • Klinik St. Anna

    Luzern,
    Switzerland

    Completed

  • Kantonsspital Olten

    Olten,
    Switzerland

    Active - Recruiting

  • Spital Limmattal

    Schlieren,
    Switzerland

    Completed

  • Universitätsspital Zürich

    Zurich,
    Switzerland

    Active - Recruiting

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