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

NCT03149471 | Unknown

• 1 other identifier: ENOPAT_PE
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Augmentation Index (AI)

  2 years

• HRV

  2 years

• Biochemistry

  2 years

Study Arms (2)

Normal endothelial function

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

Diagnostic Test: Endothelial dysfunction test

Endothelial dysfunction group

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

Diagnostic Test: Endothelial dysfunction test

Interventions

Endothelial dysfunction test DIAGNOSTIC_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.

Endothelial dysfunction group; Normal endothelial function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Related Publications (12)

• 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. No abstract available.

  PMID: 18296591 BACKGROUND

• 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. doi: 10.1160/TH07-03-0212.

  PMID: 17938798 BACKGROUND

• 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.

  PMID: 22959540 BACKGROUND

• 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.

  PMID: 22672974 BACKGROUND

• 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.

  PMID: 11487036 BACKGROUND

• Becattini C, Cohen AT, Agnelli G, Howard L, Castejon B, Trujillo-Santos J, Monreal M, Perrier A, Yusen RD, Jimenez 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.

  PMID: 26204122 BACKGROUND

• 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.

  PMID: 24182642 BACKGROUND

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

  PMID: 20972417 BACKGROUND

• 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. doi: 10.1016/j.jacc.2004.08.062.

  PMID: 15582310 BACKGROUND

• Bonetti PO, Lerman LO, Lerman A. Endothelial dysfunction: a marker of atherosclerotic risk. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):168-75. doi: 10.1161/01.atv.0000051384.43104.fc.

  PMID: 12588755 BACKGROUND

• Cai H, Harrison DG. Endothelial dysfunction in cardiovascular diseases: the role of oxidant stress. Circ Res. 2000 Nov 10;87(10):840-4. doi: 10.1161/01.res.87.10.840.

  PMID: 11073878 BACKGROUND

• 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. doi: 10.1161/01.cir.101.9.948.

  PMID: 10704159 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Nir Shlomo, MSc

CONTACT

052-7205057; nir.shlomo@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director , Cardiac Intensive Care Unit

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: May 11, 2017
• Study Start: June 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2020
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share