Pulmonary EmbolismNCT04609605
Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography
A study testing speckle tracking echocardiography in people with Pulmonary Embolism, run by Assiut University.
Trial summary
1. To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography 2. To evaluate its relationship to long term mortality. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- speckle tracking echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jan 2022
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of acute pulmonary embolism
- Age: 20 - 70 years.
Who cannot join
- coronary artery disease
- patient of Atrial fibrillation.
- Patient of impaired RV function due to chest disease (Cor-pulmonale)
- patient with impaired Ejection fraction (EF) <50%
- Moderate to severe valvular heart disease.
- Atrio-ventricular conduction disturbance.
- Poor echogenicity
Trial locations and contacts
No sites are listed yet.
About this study
- To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography
- To evaluate its relationship to long term mortality.
Read the detailed description
Pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction and stroke . The incidence of PE has been increasing ,with significant associated mortality; a recent registry of PE patients reported a mortality rate > 10% at 30 days. There are a number of emerging contemporary PE therapies, including thrombolysis, catheter intervention and surgery. Early and accurate identification of PE in patients is therefore critical. A transthoracic echocardiogram (TTE) may help when there is a clinical suspicion for PE, and its use in confirmed PE is widely recommended . A number of right atrial (RA) and right ventricular (RV) parameters have been shown to be abnormal in patients with PE . In addition, RA and RV enlargement portends a worse prognosis in these patients .
- Conditions
- Pulmonary Embolism
- Being tested
- speckle tracking echocardiography
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speckle tracking echocardiographyDevice
speckle tracking echocardiography of right ventricle
| Study group | Role | What they receive |
|---|---|---|
| patients with acute pulmonary embolism | Experimental | speckle tracking echocardiography for patient with acute pulmonary embolism Receives: Device: speckle tracking echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve management of acute pulmonary embolism
comparison between speckle tracking echocardiograpgy and conventional echocardiography in pulmonary embolism
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Said Rashwan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609605
- Sponsor's protocol ID
- speckle tracking in PE
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.
PubMed 27126645McConnell MV, Solomon SD, Rayan ME, Come PC, Goldhaber SZ, Lee RT. Regional right ventricular dysfunction detected by echocardiography in acute pulmonary embolism. Am J Cardiol. 1996 Aug 15;78(4):469-73. doi: 10.1016/s0002-9149(96)00339-6.
PubMed 8752195Fields JM, Davis J, Girson L, Au A, Potts J, Morgan CJ, Vetter I, Riesenberg LA. Transthoracic Echocardiography for Diagnosing Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Am Soc Echocardiogr. 2017 Jul;30(7):714-723.e4. doi: 10.1016/j.echo.2017.03.004. Epub 2017 May 9.
PubMed 28495379Trivedi SJ, Altman M, Stanton T, Thomas L. Echocardiographic Strain in Clinical Practice. Heart Lung Circ. 2019 Sep;28(9):1320-1330. doi: 10.1016/j.hlc.2019.03.012. Epub 2019 Apr 12.
PubMed 31064715
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography
- ClinicalTrials.gov ID
- NCT04609605
- Acronym / sponsor ID
- speckle tracking in PE
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 30 Oct 2020 (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.
- To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography
- To evaluate its relationship to long term mortality.
Detailed description
Pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction and stroke . The incidence of PE has been increasing ,with significant associated mortality; a recent registry of PE patients reported a mortality rate > 10% at 30 days. There are a number of emerging contemporary PE therapies, including thrombolysis, catheter intervention and surgery. Early and accurate identification of PE in patients is therefore critical. A transthoracic echocardiogram (TTE) may help when there is a clinical suspicion for PE, and its use in confirmed PE is widely recommended . A number of right atrial (RA) and right ventricular (RV) parameters have been shown to be abnormal in patients with PE . In addition, RA and RV enlargement portends a worse prognosis in these patients .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute pulmonary embolism | Experimental | Device: speckle tracking echocardiographyspeckle tracking echocardiography for patient with acute pulmonary embolism |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of acute pulmonary embolism
- Age: 20 - 70 years.
Key exclusion criteria (7 listed)
- coronary artery disease
- patient of Atrial fibrillation.
- Patient of impaired RV function due to chest disease (Cor-pulmonale)
- patient with impaired Ejection fraction (EF) <50%
- Moderate to severe valvular heart disease.
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 |
|---|---|---|
| speckle tracking echocardiographyspeckle tracking echocardiography of right ventricle | Device | patients with acute pulmonary embolism |
Primary outcome
improve management of acute pulmonary embolism
Time frame: baseline
comparison between speckle tracking echocardiograpgy and conventional echocardiography in pulmonary embolism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 27126645Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.
- Background: PubMed 8752195McConnell MV, Solomon SD, Rayan ME, Come PC, Goldhaber SZ, Lee RT. Regional right ventricular dysfunction detected by echocardiography in acute pulmonary embolism. Am J Cardiol. 1996 Aug 15;78(4):469-73. doi: 10.1016/s0002-9149(96)00339-6.
- Background: PubMed 28495379Fields JM, Davis J, Girson L, Au A, Potts J, Morgan CJ, Vetter I, Riesenberg LA. Transthoracic Echocardiography for Diagnosing Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Am Soc Echocardiogr. 2017 Jul;30(7):714-723.e4. doi: 10.1016/j.echo.2017.03.004. Epub 2017 May 9.
- Background: PubMed 31064715Trivedi SJ, Altman M, Stanton T, Thomas L. Echocardiographic Strain in Clinical Practice. Heart Lung Circ. 2019 Sep;28(9):1320-1330. doi: 10.1016/j.hlc.2019.03.012. Epub 2019 Apr 12.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing speckle tracking echocardiography in people with 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 2 inclusion and 7 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 3 Nov 2020. 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 Mahmoud Said rashwan, master degree of cardiology (01007949203, dr.ma7moudsaid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improve management of 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 NCT04609605, which also lists 4 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 3 Nov 2020.