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

• Conditions: Pulmonary Disease
• Interventions: Diagnostic Test: Endothelial dysfunction test

• Registration Number: NCT03149471
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2017-03-20
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-09
• Last Update Submitted: 2017-05-09
• Study First Posted: 2017-05-11
• Last Update Posted: 2017-05-11
• Study Start: 2017-06
• Primary Completion: 2019-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal endothelial function	Endothelial dysfunction test	patients diagnosed with PE and have normal endothelial function test- RHI score \>=1.67
Endothelial dysfunction group	Endothelial dysfunction test	patients diagnosed with PE and have endothelial function- RHI\<1.67

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Augmentation Index (AI)	2 years	To investigate the association between arterial stiffness as measured by Augmentation Index and post PE complications.