CTEPH PredictorsNCT05784896
CTEPH Predictors Following Acute Pulmonary Embolism
An observational study of CTEPH Predictors, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CTEPH Predictors
- What is being tested?
- v/Q scanning & CT pulmonary angiography & Echocardiography
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2023to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Patients with congenital or acquired heart diseases. Patients with chronic chest diseases. Patients previously diagnosed chronic thromboembolic pulmonary hypertension by V/Q scan.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictors Of Chronic Thromboembolic Pulmonary Hypertension Following Acute Pulmonary Embolism
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.
Read the detailed description
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
- CTEPH Predictors
- Being tested
- v/Q scanning & CT pulmonary angiography & Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
v/Q scanning & CT pulmonary angiography & EchocardiographyDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify risk factors for devolping chronic thromboembolic pulmonary hypertention after acute pulmonary embolism.
Follow up to patients with acute pulmonary embolism after 3 months with V/Q scanning and ECHO
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CTEPH PredictorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gamal Abd Elhamied, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784896
- Sponsor's protocol ID
- CTEPH predictors in acute PE
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26509468Dentali 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.
PubMed 19193397Auger 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.
PubMed 17338940Dyspnea. 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.
PubMed 9872857Klok 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.
PubMed 21450333Bova 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.
PubMed 29631073
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors Of Chronic Thromboembolic Pulmonary Hypertension Following Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05784896
- Acronym / sponsor ID
- CTEPH predictors in acute PE
- Conditions
- CTEPH Predictors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with congenital or acquired heart diseases. Patients with chronic chest diseases. Patients previously diagnosed chronic thromboembolic pulmonary hypertension by V/Q scan.
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 |
|---|---|---|
| v/Q scanning & CT pulmonary angiography & EchocardiographyEchocardiography ( 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. | Diagnostic test | – |
Primary outcome
Identify risk factors for devolping chronic thromboembolic pulmonary hypertention after acute pulmonary embolism.
Time frame: baseline
Follow up to patients with acute pulmonary embolism after 3 months with V/Q scanning and ECHO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 26509468Klok 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.
- Background: PubMed 19193397Dentali 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.
- Background: PubMed 17338940Auger 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.
- Background: PubMed 9872857Dyspnea. 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.
- Background: PubMed 21450333Klok 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.
- Background: PubMed 29631073Bova 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.
Related trials for CTEPH Predictors
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Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Embolism
Chronic Thromboembolic Pulmonary Hypertension
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.
Questions about this trial
What is this clinical trial studying?
An observational study of CTEPH Predictors, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Gamal, Assistant lecturer (01033826969, asmaanafady5922@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify risk factors for devolping chronic thromboembolic pulmonary hypertention after acute pulmonary embolism. (time frame: baseline). 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 NCT05784896, which also lists 6 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 27 Mar 2023.