Clinical trial NCT03149471: The Role of Endothelial Function Test in Risk Stratification for Early and Late Complications After Pulmonary Embolism
Official title: The Role of Endothelial Function Test in Risk Stratification for Early and Late Complications After Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 Stable patients hospitalized in ICCU or Cardiology department with a diagnosis of acute PE according to CT scanning or nuclear imaging

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post PE complications
timeFrame: 2 years
Secondary outcomes:
measure: Augmentation Index (AI)
timeFrame: 2 years
measure: HRV
timeFrame: 2 years
measure: Biochemistry
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
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