Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00470587
First received: May 7, 2007
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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 700 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 (troponin T). All patients will be contacted by telephone at 6, 12 and 24 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
Myocardial Infarction
Angina, Unstable

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

EDTA plasma


Estimated Enrollment: 3500
Study Start Date: April 2006
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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 1000 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 (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 and 24 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470587

Contacts
Contact: Raphael Twerenbold, MD 0041-61-2652525 rtwerenbold@uhbs.ch
Contact: Christian Mueller, MD 0041-61-2652525 chmueller@uhbs.ch

Locations
Italy
Emergency Department San Martino Hospital Recruiting
Genova, Italy
Contact: Paola Ballarino, MD         
Sub-Investigator: Paola Ballarino, MD         
Spain
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Joaquim Gea, MD         
Principal Investigator: Joaquim Gea, MD         
Switzerland
University Hospital of Basel Recruiting
Basel, Switzerland, 4031
Contact: Raphael Twerenbold, MD    0041-61-2652525    rtwerenbold@uhbs.ch   
Contact: Christian Mueller, MD    0041-61-2652525    chmueller@uhbs.ch   
Sub-Investigator: Tobias Reichlin, MD         
Sub-Investigator: Raphael Twerenbold, MD         
Sub-Investigator: Willibald Hochholzer, MD         
Principal Investigator: Christian Mueller, Prof.         
Sub-Investigator: Miriam Reiter, MD         
Sub-Investigator: Philip Haaf, MD         
Sub-Investigator: Mira Mueller, MD         
Sub-Investigator: Maria Rubini Gimenez, MD         
University Hospital Bruderholz Recruiting
Bruderholz, Switzerland
Contact: Reto Krapf, MD         
Sub-Investigator: Reto Krapf, MD         
Klinik St. Anna Recruiting
Luzern, Switzerland
Contact: Martin Nufer, MD         
Sub-Investigator: Martin Nufer, MD         
Kantonsspital Olten Recruiting
Olten, Switzerland
Contact: Susanne Ernst, M.D.         
Sub-Investigator: Susanne Ernst, M.D.         
Sub-Investigator: Stefano Bassetti, MD         
Spital Limmattal Recruiting
Schlieren, Switzerland
Contact: Stephan Steuer, M.D.         
Sub-Investigator: Stephan Steuer, M.D.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Principal Investigator: Christian Mueller, MD University Hospital of Basel
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00470587     History of Changes
Other Study ID Numbers: APACE
Study First Received: May 7, 2007
Last Updated: April 4, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
chest pain
myocardial infarction
unstable angina

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 21, 2014