CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients
NCT ID: NCT03083093
Last Updated: 2021-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
100 participants
OBSERVATIONAL
2017-05-01
2018-03-01
Brief Summary
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Detailed Description
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Three experienced thorax radiologists with specific expertise on acute PE and CTEPH will blindly assess the index CTPAs of the study population. In addition to the binominal judgement whether CTEPH signs are already present (or not), the presence of the following items will be scored by all 3 readers independently:
* Webs or bands
* Residual thrombus attached to the vascular wall
* Complete occlusion /retraction
* Mosaic perfusion
* Pulmonary infarct
* Parenchymal bands
* Bronchial arteries
* Right atrial (RA) dilatation
* Right ventricle (RV) dilatation
* Flattening of the septum
* Right ventricle (RV) hypertrophy
* Dilated truncus pulmonalis
* Cardiac signs of pulmonary hypertension (PH)
* Further remarks (free text)
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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CTEPH patients
the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE
The initial CTPA will be reviewed
The initial CTPA will be reviewed
non CTEPH patients
the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
The initial CTPA will be reviewed
The initial CTPA will be reviewed
Interventions
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The initial CTPA will be reviewed
The initial CTPA will be reviewed
Eligibility Criteria
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Inclusion Criteria
* availability of the CTPA scan of the initial PE episode
Exclusion Criteria
* Patients who did not receive anticoagulation after PE diagnosis
* Patients under the age of 18 years old
* Patients in the control group with a follow-up duration of less than 2 years after the index PE episode
* Use of a CTPA scanner with less than 32-detector rows
18 Years
ALL
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Erik Klok
principal investigator
Principal Investigators
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F.A. Klok, MD PhD
Role: PRINCIPAL_INVESTIGATOR
LUMC department of thormbosis and hemostasis
Locations
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LUMC
Leiden, , Netherlands
Countries
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References
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Konstantinides SV. 2014 ESC Guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Dec 1;35(45):3145-6. doi: 10.1093/eurheartj/ehu393. No abstract available.
Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
Tunariu N, Gibbs SJ, Win Z, Gin-Sing W, Graham A, Gishen P, Al-Nahhas A. Ventilation-perfusion scintigraphy is more sensitive than multidetector CTPA in detecting chronic thromboembolic pulmonary disease as a treatable cause of pulmonary hypertension. J Nucl Med. 2007 May;48(5):680-4. doi: 10.2967/jnumed.106.039438.
Dogan H, de Roos A, Geleijins J, Huisman MV, Kroft LJ. The role of computed tomography in the diagnosis of acute and chronic pulmonary embolism. Diagn Interv Radiol. 2015 Jul-Aug;21(4):307-16. doi: 10.5152/dir.2015.14403.
Kim NH, Delcroix M, Jenkins DP, Channick R, Dartevelle P, Jansa P, Lang I, Madani MM, Ogino H, Pengo V, Mayer E. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D92-9. doi: 10.1016/j.jacc.2013.10.024.
Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.
Lang IM, Madani M. Update on chronic thromboembolic pulmonary hypertension. Circulation. 2014 Aug 5;130(6):508-18. doi: 10.1161/CIRCULATIONAHA.114.009309. No abstract available.
Lang IM, Simonneau G, Pepke-Zaba JW, Mayer E, Ambroz D, Blanco I, Torbicki A, Mellemkjaer S, Yaici A, Delcroix M. Factors associated with diagnosis and operability of chronic thromboembolic pulmonary hypertension. A case-control study. Thromb Haemost. 2013 Jul;110(1):83-91. doi: 10.1160/TH13-02-0097. Epub 2013 May 16.
van der Bijl N, Klok FA, Huisman MV, van Rooden JK, Mertens BJA, de Roos A, Kroft LJM. Measurement of right and left ventricular function by ECG-synchronized CT scanning in patients with acute pulmonary embolism: usefulness for predicting short-term outcome. Chest. 2011 Oct;140(4):1008-1015. doi: 10.1378/chest.10-3174. Epub 2011 Apr 7.
Klok FA, Zondag W, van Kralingen KW, van Dijk AP, Tamsma JT, Heyning FH, Vliegen HW, Huisman MV. Patient outcomes after acute pulmonary embolism. A pooled survival analysis of different adverse events. Am J Respir Crit Care Med. 2010 Mar 1;181(5):501-6. doi: 10.1164/rccm.200907-1141OC. Epub 2009 Dec 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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G17.014
Identifier Type: -
Identifier Source: org_study_id
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