The Role of Endothelial Function Test in Risk Stratification for Early and Late Complications After Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the association between endothelial dysfunction, measured by RHI as assessed by the peripheral arterial tonometry method, and PE complications defined as re-event of PE or DVT, systemic embolism or all-cause mortality

Detailed Description
-----------------
200 Patients will be identified through routine daily scanning of imaging records (CT, Echocardiography) for patients diagnosed with PE. Presenting signs and symptoms as well as clinical and imaging findings during the initial presentation and hospitalization will be incorporated into a computerized pre-specified electronic CRF. During hospitalization, an endothelial function test will be performed 48 hours post admission. A trained technician will perform the test using the EndoPAT device in order to assess patient RHI, a score less than 1.67 will be considerate as endothelial dysfunction. Patients will then be followed for pre-specified clinical events of up to 1 year post discharge and especially the development of chronic thromboembolic pulmonary disease, post thrombotic syndrome and clinical events. RHI will be assessed during 1-year follow up visit.

Official Title
-----------------
The Role of Endothelial Function Test in Risk Stratification for Early and Late Complications After Pulmonary Embolism

Conditions
-----------------
Pulmonary Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Endothelial dysfunction test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old Patient is hospitalized with the diagnosis of acute PE Clinically stable patients. Clinical diagnosis of PE based on CT scan or nuclear imaging. Willing and able to sign informed consent Exclusion Criteria: Previous myocardial infarction during the last 3 months. Planned surgery or PCI. Inability to perform endothelial function test. Current participation in clinical trial. Substrate or drug abuse or alcohol consumption.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal endothelial function<br>patients diagnosed with PE and have normal endothelial function test- RHI score >=1.67 | Diagnostic Test: Endothelial dysfunction test<br>* The endothelial function test will be assessed after 48 hours post admission and 1 year post discharge using the non-invasive Endo-PAT2000 device. The device is intended for use as a diagnostic aid in the detection of coronary artery endothelial dysfunction (positive or negative) using a reactive hyperemia procedure. It is based on the use of Peripheral Arterial Tone (PAT) signal technology, during a clinically established procedure, which measure post-ischemic vascular responsiveness following upper arm blood flow occlusion.<br>|
| Endothelial dysfunction group<br>patients diagnosed with PE and have endothelial function- RHI<1.67 | Diagnostic Test: Endothelial dysfunction test<br>* The endothelial function test will be assessed after 48 hours post admission and 1 year post discharge using the non-invasive Endo-PAT2000 device. The device is intended for use as a diagnostic aid in the detection of coronary artery endothelial dysfunction (positive or negative) using a reactive hyperemia procedure. It is based on the use of Peripheral Arterial Tone (PAT) signal technology, during a clinically established procedure, which measure post-ischemic vascular responsiveness following upper arm blood flow occlusion.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post PE complications | The aim of this study is to investigate the association between endothelial dysfunction, measured by RHI as assessed by the peripheral arterial tonometry method, and PE complications defined as re-event of PE or DVT, systemic embolism or all-cause mortality | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Augmentation Index (AI) | To investigate the association between arterial stiffness as measured by Augmentation Index and post PE complications. | 2 years | 
| HRV | To investigate the association between Heart Rate Variability and post PE complications. | 2 years | 
| Biochemistry | To assess the association between troponin levels to post PE complications | 2 years |