CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients

Pulmonary Embolism Clinical Trial

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Official title:

Identification of CTEPH on Standard Computerised Tomography Pulmonary Angiography Performed in the Work-up of Suspected Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083093
• Other study ID #: G17.014
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2021
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study the investigators will evaluate whether more careful reading (than the current standard) of routine computerised tomography pulmonary angiography (CTPA) performed in the clinical work-up of suspected (pulmonary embolism (PE) will differentiate patients with acute PE from those with more chronic or acute on chronic PE, which could be indicative of the presence of chronic thromboembolic pulmonary hypertension (CTEPH)"

Description:

The investigators will study 50 consecutive patients diagnosed with CTEPH as well as 50 patients diagnosed with acute PE in whom CTEPH was ruled out 2 years after the PE diagnosis by sequential echocardiography. The cases and controls will be matched based on the right-to-left ventrilcle diameter ratio.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients after an acute PE diagnosed with CTEPH according to current guidelines, patients after an acute PE in whom CTEPH is excluded by follow-up echocardiography

• availability of the CTPA scan of the initial PE episode

Exclusion Criteria:

• CTEPH diagnosis based on other test results than a RHC

• 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

Related Conditions & MeSH terms

• CTEPH
• Early Diagnosis
• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• The initial CTPA will be reviewed
The initial CTPA will be reviewed

Locations

Country	Name	City	State
Netherlands	LUMC	Leiden

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (11)

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. Review. — View Citation

Galiè 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. Erratum in: Eur Respir J. 2015 Dec;46(6):1855-6. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Lang IM, Madani M. Update on chronic thromboembolic pulmonary hypertension. Circulation. 2014 Aug 5;130(6):508-18. doi: 10.1161/CIRCULATIONAHA.114.009309. Review. — View Citation

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. Review. — View Citation

Lang IM, Simonneau G, Pepke-Zaba JW, Mayer E, Ambrož 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. — View Citation

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, Barberà JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jaïs 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE.	The sensitivity of CTPA is determined by calculating the proportion of scans that are read as "positive for the CTEPH specific radiological pattern" in patients with confirmed CTEPH and the specificity is determined by calculating the proportion of scans that are read as "negative for the CTEPH specific radiological pattern" in patients without CTEPH.	1 year