Association of Endothelial Function and Clinical Outcomes in Subjects Admitted to Chest Pain Unit
| Status: | Completed |
|---|---|
| Conditions: | Angina, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | October 2012 |
| End Date: | December 2015 |
| Contact: | Michael Shechter, MD |
| Email: | Michael.Shechter@sheba.health.gov.il |
| Phone: | +97235302617 |
The Impact of Short- and Long-term Endothelial Function Assessment by Peripheral Arterial Tonometry (PAT) on Clinical Outcome in Subjects Admitted to Chest Pain Unit (CPU)
It is recognized that endothelial dysfunction is a major factor contributing to the
atherogenic process. Abnormal function of the endothelium is detectable prior to obvious
intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction
is a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its
complications. Measurement of peripheral vasodilator response with fingertip peripheral
arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging
as a useful method for assessing vascular function. EndoPAT may be a potential valid test
increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain
unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a
relatively fast non-invasive bedside test, relatively low-cost and has no side effects.
Therefore, the primary objective of the study is to test the hypothesis that abnormal
endothelial function as assessed by EndoPAT testing will increase the prediction of the
short (in-hospital) and long-term (1-year) outcome of patients presenting to the chest pain
unit.
atherogenic process. Abnormal function of the endothelium is detectable prior to obvious
intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction
is a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its
complications. Measurement of peripheral vasodilator response with fingertip peripheral
arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging
as a useful method for assessing vascular function. EndoPAT may be a potential valid test
increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain
unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a
relatively fast non-invasive bedside test, relatively low-cost and has no side effects.
Therefore, the primary objective of the study is to test the hypothesis that abnormal
endothelial function as assessed by EndoPAT testing will increase the prediction of the
short (in-hospital) and long-term (1-year) outcome of patients presenting to the chest pain
unit.
All subjects admitted to the CPU with low to moderate probability for CAD and negative
troponin, will undergo the following tests upon arrival following clinical evaluation and
their consenting to the study: resting ECG, EndoPAT testing and then after stress nuclear
imaging or stress echocardiography. Except for EndoPAT testing, all other tests will be
conducted according to the routine CPU protocol.
The results of the EndoPAT will be blinded to the treating physician until the end of the
study and all patients will be managed according to the current CPU protocol, including 24-h
Holter monitoring, repeat resting ECG and exercise tests (nuclear SPECT imaging or stress
echocardiography, whichever is available) in addition to repeat clinical and troponin tests
evaluations.
All clinical data of the recruited subjects the will be recorded and evaluated after
completion of the study.
Long-term clinical follow-up All patients will be followed by telephone contact after 6 and
12 months for combined major adverse cardiovascular end-points (MACE) which include
all-cause mortality, non-fatal myocardial infarction, hospitalization for heart failure or
angina pectoris, stroke, coronary artery bypass grafting and percutaneous coronary
interventions, by physicians who will be blinded to the patients' baseline clinical status
and endothelial function (assessed by EndoPAT) results. All MACE will be validated by review
of medical records by senior cardiologists blinded to the endothelial function results. In
addition, on-line access to this information will facilitate verification and safe
documentation of all events. In addition, written medical records will be reviewed by
cardiologists in the event of any death, hospitalization and/or angina pectoris.
At the end of the study the cost effectiveness on prediction of short (in-hospital) and long
(6 months, and 1 year) of EndoPAT will be assessed and will be compared to the stress tests
(nuclear imaging and/or echocardiography).
troponin, will undergo the following tests upon arrival following clinical evaluation and
their consenting to the study: resting ECG, EndoPAT testing and then after stress nuclear
imaging or stress echocardiography. Except for EndoPAT testing, all other tests will be
conducted according to the routine CPU protocol.
The results of the EndoPAT will be blinded to the treating physician until the end of the
study and all patients will be managed according to the current CPU protocol, including 24-h
Holter monitoring, repeat resting ECG and exercise tests (nuclear SPECT imaging or stress
echocardiography, whichever is available) in addition to repeat clinical and troponin tests
evaluations.
All clinical data of the recruited subjects the will be recorded and evaluated after
completion of the study.
Long-term clinical follow-up All patients will be followed by telephone contact after 6 and
12 months for combined major adverse cardiovascular end-points (MACE) which include
all-cause mortality, non-fatal myocardial infarction, hospitalization for heart failure or
angina pectoris, stroke, coronary artery bypass grafting and percutaneous coronary
interventions, by physicians who will be blinded to the patients' baseline clinical status
and endothelial function (assessed by EndoPAT) results. All MACE will be validated by review
of medical records by senior cardiologists blinded to the endothelial function results. In
addition, on-line access to this information will facilitate verification and safe
documentation of all events. In addition, written medical records will be reviewed by
cardiologists in the event of any death, hospitalization and/or angina pectoris.
At the end of the study the cost effectiveness on prediction of short (in-hospital) and long
(6 months, and 1 year) of EndoPAT will be assessed and will be compared to the stress tests
(nuclear imaging and/or echocardiography).
Inclusion Criteria:
- All subjects admitted to the CPU with low to moderate probability for CAD and
negative troponin.
Exclusion Criteria:
- Subjects with chest pain and positive troponin.
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