CTEPHInShapeIIINCT03083093
CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients
An observational study of CTEPH and Pulmonary Embolism, run by Leiden University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTEPH, Pulmonary Embolism, Early Diagnosis
- What is being tested?
- The initial CTPA will be reviewed
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2017to 1 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of CTEPH on Standard Computerised Tomography Pulmonary Angiography Performed in the Work-up of Suspected Pulmonary Embolism
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)"
Read the detailed 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)
- Conditions
- CTEPH, Pulmonary Embolism, Early Diagnosis
- Being tested
- The initial CTPA will be reviewed
- Medical subject headings
- Pulmonary Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The initial CTPA will be reviewedDiagnostic test
The initial CTPA will be reviewed
| Study group | Role | What they receive |
|---|---|---|
| CTEPH patients | the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE Receives: 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 Receives: Diagnostic Test: The initial CTPA will be reviewed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 May 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CTEPHStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Erik Klok, Leiden University Medical Center
- Investigators
- F.A. Klok, MD PhD, Principal investigator, LUMC department of thormbosis and hemostasis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083093
- Sponsor's protocol ID
- G17.014
- Acronym
- InShapeIII
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2017
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: this has to be planned
Publications
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.
PubMed 25452462Galie 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.
PubMed 26318161Pepke-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.
PubMed 21969018Tunariu 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.
PubMed 17475953Dogan 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.
PubMed 26133321Kim 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.
PubMed 24355646Lang 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.
PubMed 22700839Lang 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.
PubMed 25092279Lang 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.
PubMed 23677493van 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.
PubMed 21474573Klok 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.
PubMed 19965808
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of CTEPH on Standard Computerised Tomography Pulmonary Angiography Performed in the Work-up of Suspected Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03083093
- Acronym / sponsor ID
- InShapeIII / G17.014
- Conditions
- CTEPH, Pulmonary Embolism, Early Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)"
Detailed 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)
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTEPH patients | – | Diagnostic Test: The initial CTPA will be reviewedthe initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE |
| non CTEPH patients | – | Diagnostic Test: The initial CTPA will be reviewedthe initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The initial CTPA will be reviewedThe initial CTPA will be reviewed | Diagnostic test | CTEPH patients, non CTEPH patients |
Primary outcome
To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE.
Time frame: 1 year
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25452462Konstantinides 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.
- Background: PubMed 26318161Galie 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.
- Background: PubMed 21969018Pepke-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.
- Background: PubMed 17475953Tunariu 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.
- Background: PubMed 26133321Dogan 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.
- Background: PubMed 24355646Kim 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.
- Background: PubMed 22700839Lang 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.
- Background: PubMed 25092279Lang 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.
- Background: PubMed 23677493Lang 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.
- Background: PubMed 21474573van 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.
- Background: PubMed 19965808Klok 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.
- Individual participant dataSharing planned: Undecided. this has to be planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F.A. Klok, MD PhD principal investigator
LUMC department of thormbosis and hemostasis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CTEPH and Pulmonary Embolism, run by Leiden University Medical Center at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE. (time frame: 1 year). 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 NCT03083093, which also lists 11 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 19 Apr 2021.