Pulmonary Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTEndothelial dysfunction test
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.
Sponsors
Sheba Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years old 2. Patient is hospitalized with the diagnosis of acute PE 3. Clinically stable patients. 4. Clinical diagnosis of PE based on CT scan or nuclear imaging. 5. Willing and able to sign informed consent
Exclusion criteria
1. Previous myocardial infarction during the last 3 months. 2. Planned surgery or PCI. 3. Inability to perform endothelial function test. 4. Current participation in clinical trial. 5. Substrate or drug abuse or alcohol consumption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post PE complications | 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Augmentation Index (AI) | 2 years | To investigate the association between arterial stiffness as measured by Augmentation Index and post PE complications. |
| HRV | 2 years | To investigate the association between Heart Rate Variability and post PE complications. |
| Biochemistry | 2 years | To assess the association between troponin levels to post PE complications |
Contacts
Primary ContactNir Shlomo, MSc
Outcome results
None listed