Myocardial Ischemia Detection for Early Identification of Patients With Ischemic Chest Pain



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:7/12/2017
Start Date:January 2014
End Date:December 2016

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The purpose of this study is to evaluate whether new novel markers from the clinical
electrocardiogram (EKG), which have been used as non-invasive measures of heart disease, can
detect coronary artery disease in patients with chest pain. The researchers are especially
interested in studying how changes in these unique waves evolve over time with rest and
activity. It is hoped that the findings will be helpful in differentiating patients with
cardiac chest pain at emergency departments from those with non-cardiac chest pain, as early
identification can accelerate treatment and save lives.

Eligible participants are those age 18 and older who have been referred for a nuclear stress
test at University of Pittsburgh Medical Center Presbyterian Hospital to rule out coronary
artery disease as part of their clinical care.

Acute Coronary Syndrome (ACS) is the leading cause of death worldwide. Differentiating ACS
from other non-ischemic chest pain is imperative in emergency medicine and missed myocardial
infarction remains one of the highest sources of medical malpractice in Emergency Departments
(ED). At the same time, economic pressures and limited resources demand that physicians avoid
hospital admission or protracted observation for every patient with chest pain or suspicious
symptoms. In the absence of clear ST elevation (STE) on the electrocardiogram (ECG), ED
providers have no reliable tools to quickly triage non-STE (NSTE) ACS patients. Current
guidelines rely on blood biomarkers (e.g. cardiac enzymes) to identify this syndrome and do
not completely describe ischemic ECG changes associated with it. ED Providers will need to
delay the management of these high risk patients until cardiac biomarkers are withdrawn,
analyzed, and interpreted. This results in greater mortality rates in NSTE-ACS patients and
overburdens the healthcare system. The prolonged observation times at EDs and unnecessary
admissions are just additional consequences that overuse nursing times and exacerbate nursing
shortage.

ECG changes other than ST elevation and dynamic ECG changes are a rich opportunity for
improving diagnostics. This proposal intends to provide new insights into how ischemic
repolarization changes evolve over time in the subacute phase of myocardial ischemia. Sixty
patients with suspected coronary artery disease referred for nuclear cardiac stress testing
will be included. Resting 12-lead ECGs will be obtained before the stress test and one after
the stress test but before the nuclear scan. Alterations in novel, computerized T wave
indices will be correlated with focal myocardial ischemia seen on nuclear scans. Repeated
Measures ANOVA with between group comparisons, and Generalized Estimation Equation will be
used in the analysis. The results will provide insight on the diagnostic value of different
novel T wave indices to detect myocardial ischemia. Results from this study will provide
tools for ED providers to distinguish ACS from non-ischemic chest pain patients early in the
triage process, especially in the absence of STE that constitutes the common standard
nowadays.

Inclusion Criteria:

- adults > 18 years of age

- referred for nuclear cardiac stress testing for suspected coronary artery disease.

There will be no restrictions to sex or race. Children and teens are less likely to have
ischemic etiology of chest pain, justifying their exclusion. To optimize the clinical
utility, there will be no exclusion criteria based on previous medical history,
medications, or presenting chief complaint; all consecutive patients will be eligible.

Exclusion Criteria:

- Patients with un-interpretable ECGs or their ECG shows known secondary repolarization
abnormalities (i.e. bundle branch blocks, ventricular hypertrophy, channelopathies,
early repolarization) will be excluded. Of note, as per clinical guidelines, these
patients do not get usually referred for exercise treadmill testing. This will improve
the recruitment process of this study.
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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