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

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03149471
• Other study ID #: ENOPAT_PE
• Status: Not yet recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: May 9, 2017
• Start date: June 2017
• Est. completion date: April 2020

Study information

• Verified date: May 2017
• Source: Sheba Medical Center
• Contact: Nir Shlomo, MSc
• Phone: 052-7205057
• Email: nir.shlomo[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Lung Diseases
• Pulmonary Disease
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Endothelial 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

References & Publications (12)

Axtell AL, Gomari FA, Cooke JP. Assessing endothelial vasodilator function with the Endo-PAT 2000. J Vis Exp. 2010 Oct 15;(44). pii: 2167. doi: 10.3791/2167. — View Citation

Becattini C, Cohen AT, Agnelli G, Howard L, Castejón B, Trujillo-Santos J, Monreal M, Perrier A, Yusen RD, Jiménez D. Risk Stratification of Patients With Acute Symptomatic Pulmonary Embolism Based on Presence or Absence of Lower Extremity DVT: Systematic Review and Meta-analysis. Chest. 2016 Jan;149(1):192-200. doi: 10.1378/chest.15-0808. Epub 2016 Jan 6. Review. — View Citation

Bonetti PO, Lerman LO, Lerman A. Endothelial dysfunction: a marker of atherosclerotic risk. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):168-75. Review. — View Citation

Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. — View Citation

Cai H, Harrison DG. Endothelial dysfunction in cardiovascular diseases: the role of oxidant stress. Circ Res. 2000 Nov 10;87(10):840-4. Review. — View Citation

Centers for Disease Control and Prevention (CDC).. Venous thromboembolism in adult hospitalizations - United States, 2007-2009. MMWR Morb Mortal Wkly Rep. 2012 Jun 8;61(22):401-4. — View Citation

Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE).. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. — View Citation

Cohen AT, Dobromirski M, Gurwith MM. Managing pulmonary embolism from presentation to extended treatment. Thromb Res. 2014 Feb;133(2):139-48. doi: 10.1016/j.thromres.2013.09.040. Epub 2013 Oct 14. Review. — View Citation

Goldhaber SZ. Venous thromboembolism: epidemiology and magnitude of the problem. Best Pract Res Clin Haematol. 2012 Sep;25(3):235-42. doi: 10.1016/j.beha.2012.06.007. Epub 2012 Aug 9. Review. — View Citation

Heit JA, Silverstein MD, Mohr DN, Petterson TM, Lohse CM, O'Fallon WM, Melton LJ 3rd. The epidemiology of venous thromboembolism in the community. Thromb Haemost. 2001 Jul;86(1):452-63. — View Citation

Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. Review. — View Citation

Suwaidi JA, Hamasaki S, Higano ST, Nishimura RA, Holmes DR Jr, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation. 2000 Mar 7;101(9):948-54. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post PE complications	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	2 years
Secondary	Augmentation Index (AI)	To investigate the association between arterial stiffness as measured by Augmentation Index and post PE complications.	2 years
Secondary	HRV	To investigate the association between Heart Rate Variability and post PE complications.	2 years
Secondary	Biochemistry	To assess the association between troponin levels to post PE complications	2 years