Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01618123 |
| Other study ID # |
SHEBA-12-9437-MS-CTIL |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2012 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
December 2023 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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).
