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

Sheba Medical Center

Status: Unknown

Conditions: Pulmonary Disease

Treatments: Diagnostic Test: Endothelial dysfunction test

Study type: Observational

Funder types: Other

Identifiers

NCT03149471

ENOPAT_PE

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Normal endothelial function

Description:

patients diagnosed with PE and have normal endothelial function test- RHI score \>=1.67

Treatment:

Diagnostic Test: Endothelial dysfunction test

Endothelial dysfunction group

Description:

patients diagnosed with PE and have endothelial function- RHI\<1.67

Treatment:

Diagnostic Test: Endothelial dysfunction test