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Pulmonary DiseaseNCT03149471

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

An observational study of Pulmonary Disease, run by Sheba Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Disease
What is being tested?
Endothelial dysfunction test
How many people
200 participants
Where
No sites listed yet
Study dates
Jun 2017to Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 250 Stable patients hospitalized in ICCU or Cardiology department with a diagnosis of acute PE according to CT scanning or nuclear imaging

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Nir Shlomo, MSc contact

052-7205057

nir.shlomo@sheba.health.gov.il

About this study

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

Read the 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.

Being tested
Endothelial dysfunction test
Medical subject headings
Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endothelial dysfunction testDiagnostic 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.

Study groups in NCT03149471
Study groupRoleWhat they receive
Normal endothelial functionpatients diagnosed with PE and have normal endothelial function test- RHI score >=1.67
Receives: Diagnostic Test: Endothelial dysfunction test
Endothelial dysfunction grouppatients diagnosed with PE and have endothelial function- RHI<1.67
Receives: Diagnostic Test: Endothelial dysfunction test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (3)

  1. Augmentation Index (AI)

    To investigate the association between arterial stiffness as measured by Augmentation Index and post PE complications.

    Measured: 2 years

  2. HRV

    To investigate the association between Heart Rate Variability and post PE complications.

    Measured: 2 years

  3. Biochemistry

    To assess the association between troponin levels to post PE complications

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2017
  2. Study startJun 2017 (estimated)
  3. Primary completionApr 2019 (estimated)
  4. Study completionApr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03149471
Sponsor's protocol ID
ENOPAT_PE
Status last verified
May 2017
First submitted
20 Mar 2017
Last updated
11 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD plan

Publications

  • 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.

    PubMed 18296591

  • 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.

    PubMed 17938798

  • 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.

    PubMed 22959540

  • 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.

    PubMed 22672974

  • 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.

    PubMed 11487036

  • 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.

    PubMed 26204122

  • 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.

    PubMed 24182642

  • 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.

    PubMed 20972417

  • 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.

    PubMed 15582310

  • 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.

    PubMed 12588755

  • 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.

    PubMed 11073878

  • 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.

    PubMed 10704159

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, run by Sheba Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nir Shlomo, MSc (052-7205057, nir.shlomo@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post PE complications (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03149471, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.

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