Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04022668 |
| Other study ID # |
YeditepeU001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2017 |
| Est. completion date |
May 1, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Yeditepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The decision of emergency reperfusion of a suspected acute coronary artery occlusion by means
of percutaneous coronary intervention or intravenous thrombolytics depends on the presence of
a certain amount of ST-segment elevation in the electrocardiogram (ECG) as recommended by
international guidelines. However, recommended ST-segment elevation cut-off values for acute
coronary occlusion diagnosis are highly insensitive, and their evidence base is weak. The
objective of this study is to test the accuracy of various electrocardiographic patterns
(including, but not limited to, ST-segment elevation) for the diagnosis of acute coronary
occlusion. This information can serve to offer an accuracy profile for various ECG findings
and enable clinicians to define the ECG probability of an acute coronary occlusion according
to these ECG findings and clinical picture, which in turn would provide a significant
improvement in the care for patients who present to the hospital with possible coronary
occlusion. The primary analysis will be designed as a single-center, retrospective
case-control study.
Description:
In this retrospective, single-center, case-control study the investigators will seek to
compare the diagnostic accuracy of various ECG criteria to identify acute coronary occlusion
(ACO). The investigators will scan the charts of the patients presenting to emergency
department with a clinical picture suggestive of acute coronary syndrome in the specified
time period. Patients without any admission ECG will be excluded. Patients who had a final
diagnosis of myocardial infarction (MI) with or without subsequent coronary intervention will
be enrolled. These patients will be classified as ST-segment elevation (STEMI) group or
non-ST-segment elevation (NSTEMI) group according to their final diagnosis. Patient who had
been excluded for acute coronary syndrome with serial unchanging ECGs AND negative serial
troponins will constitute a third group. Allocation to each group will be continued until the
patient number in each group reaches up to 1000 patients. The dead or alive status of all
included patients will be checked from the electronic national database.
All ECGs will be reviewed by two cardiologists blinded to the angiographic and clinical
outcomes. The presence of predefined ECG findings of ACO (including, but not limited to,
current established STEMI criteria) will be recorded. The coronary angiograms of the first
two groups will be reviewed for ACO by independent investigators who are blinded to ECG
parameters. The diagnosis of acute coronary occlusion will be dependent upon angiographic
occlusion and rising cardiac biomarker levels. Because in some cases of ACO, the artery may
spontaneously open by the time of the angiogram, the investigators will need to have
surrogate endpoints: this will be culprit lesion OR acute occlusion on the angiogram AND a
sufficiently elevated peak troponin, i.e., peak troponin I > 1.0 ng/mL with a 20% change
within first 24 hours OR peak troponin T > 5.0 ng/mL, which have been shown to be highly
correlated with ACO OR cardiac arrest in a clinical scenario compatible with ACO before blood
could be withdrawn for troponin essay.
The sensitivity, specificity and diagnostic accuracy of all these predefined ECG criteria
will be sought. Also, sensitivity, specificity and diagnostic accuracy of current established
STEMI criteria will be defined. Both short- and long-term mortality of the patients with a
diagnosis of STEMI with ACO, STEMI without ACO, NSTEMI with ACO, NSTEMI without ACO and chest
pain without acute coronary syndrome will be compared.
