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Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study (APACE)

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ClinicalTrials.gov Identifier: NCT00470587
Recruitment Status : Recruiting
First Posted : May 8, 2007
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland

Study Description
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Brief 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.


Condition or disease
Myocardial Infarction Angina, Unstable

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study
Study Start Date : April 2006
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: at admission ]

Biospecimen Retention:   Samples Without DNA
EDTA plasma, Heparin, Serum, Citrate

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18 years
  • Cardiogenic shock
  • Terminal kidney disease requiring regular dialysis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470587


Contacts
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Contact: Christian Mueller, MD 0041-61-2652525 christian.mueller@usb.ch
Contact: Raphael Twerenbold, MD raphael.twerenbold@usb.ch

Locations
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Czechia
Masaryk University Brno Recruiting
Brno, Czechia
Contact: Jiri Parenica, MD       jiri.parenica@atlas.cz   
Principal Investigator: Jiri Parenica, MD         
Italy
Emergency Department San Martino Hospital Recruiting
Genova, Italy
Contact: Paola Ballarino, MD         
Sub-Investigator: Paola Ballarino, MD         
Poland
Medical University of Silesia Recruiting
Zabrze, Poland
Contact: Beata Morawiec, MD       beamorawiec@wp.pl   
Principal Investigator: Beata Morawiec, MD         
Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Oscar Miro, MD    0034-93 227 54 00    OMIRO@clinic.ub.es   
Sub-Investigator: Oscar Miro, MD         
Hospital del Mar Active, not recruiting
Barcelona, Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Contact: Francisco Javier Martín Sánchez, MD         
Switzerland
University Hospital of Basel Recruiting
Basel, Switzerland, 4031
Contact: Raphael Twerenbold, MD    0041-61-2652525    raphael.twerenbold@usb.ch   
Contact: Christian Mueller, MD    0041-61-2652525    christian.mueller@usb.ch   
Principal Investigator: Christian Mueller, MD         
Sub-Investigator: Raphael Twerenbold, MD         
Sub-Investigator: Tobias Reichlin, MD         
Sub-Investigator: Maria Rubini Gimenez, MD         
Sub-Investigator: Jasper Boeddinghaus, MD         
Sub-Investigator: Luca Köchlin, MD         
Kantonsspital Baselland, Standort Bruderholz Completed
Bottmingen, Switzerland
Kantonsspital Baselland, Standort Liestal Recruiting
Liestal, Switzerland
Contact: Jörg Leuppi, Prof.       joerg.leuppi@ksbl.ch   
Principal Investigator: Jörg Leuppi, Prof.         
Sub-Investigator: Nicolas Geigy, MD         
Klinik St. Anna Completed
Luzern, Switzerland
Kantonsspital Olten Recruiting
Olten, Switzerland
Contact: Christiane Arnold, MD         
Sub-Investigator: Christiane Arnold, MD         
Spital Limmattal Completed
Schlieren, Switzerland
Universitätsspital Zürich Recruiting
Zurich, Switzerland
Contact: Dagmar Keller, Prof.         
Principal Investigator: Dagmar Keller, Prof.         
Sub-Investigator: Albina Nowak, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Principal Investigator: Christian Mueller, MD University Hospital of Basel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. Erratum In: N Engl J Med. 2022 Nov 3;387(18):1724.

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Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00470587    
Other Study ID Numbers: APACE
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Keywords provided by Christian Müller, MD, University Hospital, Basel, Switzerland:
chest pain
myocardial infarction
unstable angina
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations