The Role of Endothelial Function Test in Risk Stratification for Early and Late Complications After Pulmonary Embolism
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pulmonary Disease
- Sponsor
- Sheba Medical Center
- Enrollment
- 200
- Primary Endpoint
- Post PE complications
- Last Updated
- 8 years ago
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.
Investigators
Dr. Shlomi Matetzky
Director , Cardiac Intensive Care Unit
Sheba Medical Center
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.
Outcomes
Primary Outcomes
Post PE complications
Time Frame: 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 Outcomes
- HRV(2 years)
- Biochemistry(2 years)
- Augmentation Index (AI)(2 years)