Pulmonary EmbolismNCT06070129
Surgery in Pulmonary Embolisms
An observational study of Pulmonary Embolism, run by Assiut University.
Trial summary
Measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- surgical pulmonary embolectomy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Feb 2026
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients with massive and sub massive pulmonary embolism entering Assiut university hospital from October 2022 to November 2025 will be taken to be treated by surgical pulmonary embolectomy. patients will be divided according to type pulmonary embolism into two groups: massive pulmonary embolism group and sub massive pulmonary embolism group all of them will have the same inclusion and exclusion criteria.
Who may be able to join
- Patient with massive pulmonary embolism or high-risk patients characterized by :
- Evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm).
- CT pulmonary angiography demonstrating a thrombus which occludes greater than 50% of the pulmonary artery (PA) cross-sectional area or occludes two or more lobar arteries.
- Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view.
- Elevated cardiac troponin T and I above normal limits.
- Patients with sub massive pulmonary embolism or intermediate -high risk characterized by:
Show all 10Show fewer
- Systolic blood pressure >90 mmHg and tachycardia (heart rate > 100 bpm).
- CT pulmonary angiography shows that 30% to 50% of the pulmonary vasculature is occluded.
- Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view.
- Elevated cardiac troponin T and I above normal limits
Who cannot join
- Patients less than 18 years of age.
- Low risk acute pulmonary embolism (less than 30% occlusion of pulmonary vasculature by CT pulmonary angiography, no signs of Rt ventricular systolic dysfunction, RV dilation or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view by Echocardiography.
- Acute on top of chronic pulmonary embolism.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Outcomes of Surgery in Patients With Massive and Sub Massive Pulmonary Embolism: ( a Single Center Experience)
Measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.
Read the detailed description
- Pulmonary embolism (PE) is one of the most important causes of mortality in cardiovascular diseases. It represents the third cause of mortality after myocardial infarction and stroke.
- Risk factors of pulmonary embolism include malignancy, recent operation, hypercoagulability, and deep venous thrombosis (DVT). DVT is the most common risk factor.
- Acute pulmonary embolism is classified into massive or high risk (characterized by evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm)) and sub massive type or intermediate-high risk (characterized by evidence of adverse effects on the RV (dysfunction and strain), with mild hypotension, tachycardia, and 1 or more of the following: RV systolic hypo kinesis, RV dilatation by echocardiogram , elevated cardiac biomarkers (troponin I), elevated serum N-terminal pro brain natriuretic peptide, or electrocardiogram changes suggestive of RV strain.).
- Treatment options of acute massive and sub massive PE include systemic thrombolytic therapy, catheter directed thrombolysis (CDT) and surgical pulmonary embolectomy (SBE).
- The outcomes of the surgical treatment to the catheter-based treatment is still a topic of interest in management of acute pulmonary embolism.
- This study aims to measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.
- Conditions
- Pulmonary Embolism
- Being tested
- surgical pulmonary embolectomy
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical pulmonary embolectomyProcedure or surgery
open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus
| Study group | Role | What they receive |
|---|---|---|
| Patients with massive pulmonary embolism or high-risk patients | * Characterized by evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm).
* CT pulmonary angiography demonstrating a thrombus which occludes greater than 50% of the pulmonary artery (PA) cross-sectional area or occludes two or more lobar arteries.
* Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view.
* Elevated cardiac troponin T and I above normal limits. Receives: Procedure: surgical pulmonary embolectomy | |
| Patients with sub massive pulmonary embolism or intermediate -high risk | * Systolic blood pressure >90 mmHg and tachycardia (heart rate > 100 bpm).
* CT pulmonary angiography shows that 30% to 50% of the pulmonary vasculature is occluded.
* Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunctions, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view.
* Elevated cardiac troponin T and I above normal limits. Receives: Procedure: surgical pulmonary embolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
number of patients died
Measured: baseline
NYHA Functional Classification.
I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: baseline
right ventricular dimension
dimensions of right ventricle in centimeter by echocardiography
Measured: baseline
left ventricular ejection fraction (EF %)
left ventricular ejection fraction (EF ) percentage by echocardiography
Measured: baseline
Secondary outcomes (1)
hospital stay days
number of days the patient stayed at hospital after the surgery
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 2026 (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 Pulmonary EmbolismStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Emad Kamel, Assiut University
- Investigators
- Ahmed EL-Minshawy, professor, Study director, professor of cardiothoracic surgery surgery departmentSameh Abdelrahman, professor, Study director, professor at cardiothoracic surgery departmentAlaa Salah, lecturer, Study director, lecturer at pulmonary disease department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070129
- Sponsor's protocol ID
- surgery in pulmonary embolisms
- Status last verified
- Sep 2023
- First submitted
- 30 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldberg JB, Spevack DM, Ahsan S, Rochlani Y, Dutta T, Ohira S, Kai M, Spielvogel D, Lansman S, Malekan R. Survival and Right Ventricular Function After Surgical Management of Acute Pulmonary Embolism. J Am Coll Cardiol. 2020 Aug 25;76(8):903-911. doi: 10.1016/j.jacc.2020.06.065.
PubMed 32819463Loyalka P, Ansari MZ, Cheema FH, Miller CC 3rd, Rajagopal S, Rajagopal K. Surgical pulmonary embolectomy and catheter-based therapies for acute pulmonary embolism: A contemporary systematic review. J Thorac Cardiovasc Surg. 2018 Dec;156(6):2155-2167. doi: 10.1016/j.jtcvs.2018.05.085. Epub 2018 Jun 8.
PubMed 30005883Meneveau N. Therapy for acute high-risk pulmonary embolism: thrombolytic therapy and embolectomy. Curr Opin Cardiol. 2010 Nov;25(6):560-7. doi: 10.1097/HCO.0b013e32833f02c5.
PubMed 20852415Azari A, Beheshti AT, Moravvej Z, Bigdelu L, Salehi M. Surgical embolectomy versus thrombolytic therapy in the management of acute massive pulmonary embolism: Short and long-term prognosis. Heart Lung. 2015 Jul-Aug;44(4):335-9. doi: 10.1016/j.hrtlng.2015.04.008.
PubMed 26077690Lin DS, Lin YS, Lee JK, Chen WJ. Short- and Long-Term Outcomes of Catheter-Directed Thrombolysis versus Pulmonary Artery Embolectomy in Pulmonary Embolism: A National Population-Based Study. J Endovasc Ther. 2022 Jun;29(3):409-419. doi: 10.1177/15266028211054763. Epub 2021 Oct 27.
PubMed 34706585Martinez Licha CR, McCurdy CM, Maldonado SM, Lee LS. Current Management of Acute Pulmonary Embolism. Ann Thorac Cardiovasc Surg. 2020 Apr 20;26(2):65-71. doi: 10.5761/atcs.ra.19-00158. Epub 2019 Oct 5.
PubMed 31588070
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes of Surgery in Patients With Massive and Sub Massive Pulmonary Embolism: ( a Single Center Experience)
- ClinicalTrials.gov ID
- NCT06070129
- Acronym / sponsor ID
- surgery in pulmonary embolisms
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 6 Oct 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.
Measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.
Detailed description
- Pulmonary embolism (PE) is one of the most important causes of mortality in cardiovascular diseases. It represents the third cause of mortality after myocardial infarction and stroke.
- Risk factors of pulmonary embolism include malignancy, recent operation, hypercoagulability, and deep venous thrombosis (DVT). DVT is the most common risk factor.
- Acute pulmonary embolism is classified into massive or high risk (characterized by evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm)) and sub massive type or intermediate-high risk (characterized by evidence of adverse effects on the RV (dysfunction and strain), with mild hypotension, tachycardia, and 1 or more of the following: RV systolic hypo kinesis, RV dilatation by echocardiogram , elevated cardiac biomarkers (troponin I), elevated serum N-terminal pro brain natriuretic peptide, or electrocardiogram changes suggestive of RV strain.).
- Treatment options of acute massive and sub massive PE include systemic thrombolytic therapy, catheter directed thrombolysis (CDT) and surgical pulmonary embolectomy (SBE).
- The outcomes of the surgical treatment to the catheter-based treatment is still a topic of interest in management of acute pulmonary embolism.
- This study aims to measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with massive pulmonary embolism or high-risk patients | – | Procedure: surgical pulmonary embolectomy* Characterized by evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm). * CT pulmonary angiography demonstrating a thrombus which occludes greater than 50% of the pulmonary artery (PA) cross-sectional area or occludes two or more lobar arteries. * Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view. * Elevated cardiac troponin T and I above normal limits. |
| Patients with sub massive pulmonary embolism or intermediate -high risk | – | Procedure: surgical pulmonary embolectomy* Systolic blood pressure >90 mmHg and tachycardia (heart rate > 100 bpm). * CT pulmonary angiography shows that 30% to 50% of the pulmonary vasculature is occluded. * Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunctions, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view. * Elevated cardiac troponin T and I above normal limits. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with massive and sub massive pulmonary embolism entering Assiut university hospital from October 2022 to November 2025 will be taken to be treated by surgical pulmonary embolectomy. patients will be divided according to type pulmonary embolism into two groups: massive pulmonary embolism group and sub massive pulmonary embolism group all of them will have the same inclusion and exclusion criteria.
Key inclusion criteria (10 listed)
- Patient with massive pulmonary embolism or high-risk patients characterized by :
- Systolic blood pressure >90 mmHg and tachycardia (heart rate > 100 bpm).
- CT pulmonary angiography shows that 30% to 50% of the pulmonary vasculature is occluded.
- Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view.
- Elevated cardiac troponin T and I above normal limits
Key exclusion criteria (3 listed)
- Patients less than 18 years of age.
- Low risk acute pulmonary embolism (less than 30% occlusion of pulmonary vasculature by CT pulmonary angiography, no signs of Rt ventricular systolic dysfunction, RV dilation or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view by Echocardiography.
- Acute on top of chronic pulmonary embolism.
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 |
|---|---|---|
| surgical pulmonary embolectomyopen heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus | Procedure or surgery | Patients with massive pulmonary embolism or high-risk patients, Patients with sub massive pulmonary embolism or intermediate -high risk |
Primary outcome
mortality
Time frame: baseline
number of patients died
NYHA Functional Classification.
Time frame: baseline
I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV Symptoms of heart failure at rest. Any physical activity causes further discomfort.
right ventricular dimension
Time frame: baseline
dimensions of right ventricle in centimeter by echocardiography
left ventricular ejection fraction (EF %)
Time frame: baseline
left ventricular ejection fraction (EF ) percentage by echocardiography
1 secondary outcome
hospital stay days
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 32819463Goldberg JB, Spevack DM, Ahsan S, Rochlani Y, Dutta T, Ohira S, Kai M, Spielvogel D, Lansman S, Malekan R. Survival and Right Ventricular Function After Surgical Management of Acute Pulmonary Embolism. J Am Coll Cardiol. 2020 Aug 25;76(8):903-911. doi: 10.1016/j.jacc.2020.06.065.
- Background: PubMed 30005883Loyalka P, Ansari MZ, Cheema FH, Miller CC 3rd, Rajagopal S, Rajagopal K. Surgical pulmonary embolectomy and catheter-based therapies for acute pulmonary embolism: A contemporary systematic review. J Thorac Cardiovasc Surg. 2018 Dec;156(6):2155-2167. doi: 10.1016/j.jtcvs.2018.05.085. Epub 2018 Jun 8.
- Background: PubMed 20852415Meneveau N. Therapy for acute high-risk pulmonary embolism: thrombolytic therapy and embolectomy. Curr Opin Cardiol. 2010 Nov;25(6):560-7. doi: 10.1097/HCO.0b013e32833f02c5.
- Background: PubMed 26077690Azari A, Beheshti AT, Moravvej Z, Bigdelu L, Salehi M. Surgical embolectomy versus thrombolytic therapy in the management of acute massive pulmonary embolism: Short and long-term prognosis. Heart Lung. 2015 Jul-Aug;44(4):335-9. doi: 10.1016/j.hrtlng.2015.04.008.
- Background: PubMed 34706585Lin DS, Lin YS, Lee JK, Chen WJ. Short- and Long-Term Outcomes of Catheter-Directed Thrombolysis versus Pulmonary Artery Embolectomy in Pulmonary Embolism: A National Population-Based Study. J Endovasc Ther. 2022 Jun;29(3):409-419. doi: 10.1177/15266028211054763. Epub 2021 Oct 27.
- Background: PubMed 31588070Martinez Licha CR, McCurdy CM, Maldonado SM, Lee LS. Current Management of Acute Pulmonary Embolism. Ann Thorac Cardiovasc Surg. 2020 Apr 20;26(2):65-71. doi: 10.5761/atcs.ra.19-00158. Epub 2019 Oct 5.
- Individual participant dataSharing planned: No
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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.
Ahmed EL-Minshawy, professor study director
professor of cardiothoracic surgery surgery department
Sameh Abdelrahman, professor study director
professor at cardiothoracic surgery department
Alaa Salah, lecturer study director
lecturer at pulmonary disease department
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, 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 10 inclusion and 3 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 6 Oct 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 Mohamed Emad, assistant lecturer (01063067860, mohamed011374@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: baseline). The study lists 4 primary outcomes in all. 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 NCT06070129, 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 6 Oct 2023.