NCT03083093

Brief 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)"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
3 years until next milestone

Results Posted

Study results publicly available

February 25, 2021

Completed
Last Updated

April 19, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

March 8, 2017

Results QC Date

February 6, 2021

Last Update Submit

March 18, 2021

Conditions

CTEPHPulmonary EmbolismEarly Diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CTEPH patients

the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE

Diagnostic Test: 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

Diagnostic Test: The initial CTPA will be reviewed

Interventions

The initial CTPA will be reviewedDIAGNOSTIC_TEST

The initial CTPA will be reviewed

CTEPH patientsnon CTEPH patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The CTPA scans of the following patient populations will be compared. The first group consists of patients with confirmed CTEPH after a prior diagnosis of acute PE. The control group consists of patients with an episode of acute PE in whom CTEPH was excluded after 2 years of follow-up by echocardiography. The CTPA scans of case and control patients will be matched according to the right-to-left ventricule diameter ratio.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LUMC

Leiden, 2333 ZA, Netherlands

Location

Related Publications (11)

  • 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.

    PMID: 25452462BACKGROUND

  • 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.

    PMID: 26318161BACKGROUND

  • 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.

    PMID: 21969018BACKGROUND

  • 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.

    PMID: 17475953BACKGROUND

  • 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.

    PMID: 26133321BACKGROUND

  • 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.

    PMID: 24355646BACKGROUND

  • 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.

    PMID: 22700839BACKGROUND

  • 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.

    PMID: 25092279BACKGROUND

  • 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.

    PMID: 23677493BACKGROUND

  • 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.

    PMID: 21474573BACKGROUND

  • 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.

    PMID: 19965808BACKGROUND

MeSH Terms

Conditions

Pulmonary EmbolismDisease

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

We studied clear-cut cases of patients with CTEPH and PE patients with RV overload who did not develop CTEPH after 2 years of follow-up, whereas, in clinical practice, the presentation of CTEPH is heterogeneous and the diagnosis is often challenging, for instance, when considering other conditions that may cause PH. Moreover, the prevalence of CTEPH in the cohort was 50%, yet this number is much lower in clinical practice.

Results Point of Contact

Title
F.A. Klok, MD PhD
Organization
LUMC
f.a.klok@LUMC.nl
003171 526 9111

Study Officials

  • F.A. Klok, MD PhD

    LUMC department of thormbosis and hemostasis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 17, 2017

Study Start

May 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 19, 2021

Results First Posted

February 25, 2021

Record last verified: 2021-03

Locations

NL(1)