CTEPH Predictors Following Acute Pulmonary Embolism

NCT ID: NCT05784896

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2025-05-31

Brief Summary

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Identify risk factors for developing chronic thromboembolic pulmonary hypertension after acute pulmonary embolism.

Determine echocardiographic predictors of chronic thromboembolic pulmonary hypertension.

Determine the radiological predictors of chronic thromboembolic pulmonary hypertension in CT pulmonary angiography.

Detailed Description

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Chronic thromboembolic pulmonary hypertension(CTEPH) is considered to be a long-term complication after acute pulmonary embolism (PE) characterized by persistent perfusion defects of pulmonary arteries caused by fibrotic remodeling. Its pathophysiology has not been fully elucidated yet, although it has been accepted that the increased pulmonary vascular resistance is caused by obstruction of pulmonary arterial vessels by organized thromboemboli and by vascular remodeling of small un obstructed vessels. (1) Although CTEPH had been thought to develop in relatively few patients post-pulmonary thromboembolism, the latest data suggest an unexpectedly high incidence of approximately 4%. (2) In addition, although there are well-defined risk factors for pulmonary thromboembolism, the risk factors for CTEPH have not yet been sufficiently defined. (3) For that reason, the determination of risk factors is of great importance for the early diagnosis of patients with CTEPH, with its high mortality and morbidity. The clinical presentation of CTEPH is characterized by non-specific symptoms and include exercise intolerance, dyspnea, fatigue, chest pain, and syncope (at exercise). These symptoms are also consistent with other more common cardiopulmonary conditions such as asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, coronary artery disease, cardiac arrhythmia or heart failure not caused by chronic pulmonary thrombi. (4) These non-specific symptoms are commonly reported by patients who suffered from an acute PE and therefore, the possibility of CTEPH can be frequently considered . The diagnostic management of CTEPH is complex. In many patients pulmonary perfusion scintigraphy, transthoracic echocardiography and conventional pulmonary angiography with determination of pulmonary hemodynamics need to be performed before the diagnosis of CTEPH can be refuted. (5)

Conditions

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CTEPH Predictors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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v/Q scanning & CT pulmonary angiography & Echocardiography

Echocardiography ( comparative follow up of the RVSF PASP TAPSE IVC).

CT pulmonary angiography with assessment of the following parameters :

Intravascular web. dilated bronchail arteries. Arterial retraction. dilated pulmonary arteries. RV/LV diameter more than 1. Flattening of interventricular septum. V/Q scanning Following ESC/ERS Guideline recommendations, V/Q is the preferred and recommended test for CTEPH. It has a sensitivity of \>96% and normal V/Q scan can rule out CTEPH . V/Q lung scintigraphy was interpreted as positive for CTEPH if there was at least one segmental or two sub-segmental mismatched perfusion defects, as proposed by the European Association of Nuclear Medicine (EANM) guidelines for the diagnosis of acute PE.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

All adult patients of both gender more than 18 yrs admitted at chest department and diagnosed by CT pulmonary angiography as acute pulmonary embolism during a period of one year will be recruited in the study.

About 80 patients as the average number of patients admitted per month is 7.

Exclusion Criteria

Patients with congenital or acquired heart diseases. Patients with chronic chest diseases. Patients previously diagnosed chronic thromboembolic pulmonary hypertension by V/Q scan.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Gamal Abd Elhamied

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Asmaa Gamal, Assistant lecturer

Role: CONTACT

01033826969

Marwan Sleem, Professor

Role: CONTACT

01009364307

References

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Klok FA, Dzikowska-Diduch O, Kostrubiec M, Vliegen HW, Pruszczyk P, Hasenfuss G, Huisman MV, Konstantinides S, Lankeit M. Derivation of a clinical prediction score for chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. J Thromb Haemost. 2016 Jan;14(1):121-8. doi: 10.1111/jth.13175. Epub 2015 Dec 29.

Reference Type BACKGROUND
PMID: 26509468 (View on PubMed)

Dentali F, Donadini M, Gianni M, Bertolini A, Squizzato A, Venco A, Ageno W. Incidence of chronic pulmonary hypertension in patients with previous pulmonary embolism. Thromb Res. 2009 Jul;124(3):256-8. doi: 10.1016/j.thromres.2009.01.003. Epub 2009 Feb 3.

Reference Type BACKGROUND
PMID: 19193397 (View on PubMed)

Auger WR, Kim NH, Kerr KM, Test VJ, Fedullo PF. Chronic thromboembolic pulmonary hypertension. Clin Chest Med. 2007 Mar;28(1):255-69, x. doi: 10.1016/j.ccm.2006.11.009.

Reference Type BACKGROUND
PMID: 17338940 (View on PubMed)

Dyspnea. Mechanisms, assessment, and management: a consensus statement. American Thoracic Society. Am J Respir Crit Care Med. 1999 Jan;159(1):321-40. doi: 10.1164/ajrccm.159.1.ats898. No abstract available.

Reference Type BACKGROUND
PMID: 9872857 (View on PubMed)

Klok FA, Surie S, Kempf T, Eikenboom J, van Straalen JP, van Kralingen KW, van Dijk AP, Vliegen HW, Bresser P, Wollert KC, Huisman MV. A simple non-invasive diagnostic algorithm for ruling out chronic thromboembolic pulmonary hypertension in patients after acute pulmonary embolism. Thromb Res. 2011 Jul;128(1):21-6. doi: 10.1016/j.thromres.2011.03.004. Epub 2011 Mar 30.

Reference Type BACKGROUND
PMID: 21450333 (View on PubMed)

Bova C, Vanni S, Prandoni P, Morello F, Dentali F, Bernardi E, Mumoli N, Bucherini E, Barbar S, Picariello C, Enea I, Pesavento R, Bottino F, Jimenez D; Bova Score Validation Study Investigators. A prospective validation of the Bova score in normotensive patients with acute pulmonary embolism. Thromb Res. 2018 May;165:107-111. doi: 10.1016/j.thromres.2018.04.002. Epub 2018 Apr 4.

Reference Type BACKGROUND
PMID: 29631073 (View on PubMed)

Other Identifiers

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CTEPH predictors in acute PE

Identifier Type: -

Identifier Source: org_study_id

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