Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00470587 |
| Other study ID # |
APACE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2006 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
April 2021 |
| Source |
University Hospital, Basel, Switzerland |
| Contact |
Christian Mueller, MD |
| Phone |
0041-61-2652525 |
| Email |
christian.mueller[@]usb.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
