Left Atrial ThrombosisNCT03662880
Uses of CMR in Detection of Left Atrial Thrombus
A study testing Cardiac Magnetic Resonance and Trans-esophageal echo in people with Left Atrial Thrombosis, run by Assiut University at 1 site in Egypt.
Trial summary
The incidence of rheumatic heart diseases have not declined in our population .Rheumatic heart diseases, often neglected by media and policy makers, is a major burden in developing countries where it causes most of the cardiovascular morbidity and mortality in young people, leading to about 250000 deaths per year… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Left Atrial Thrombosis
- What is being tested?
- Cardiac Magnetic Resonance and Trans-esophageal echo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2019to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe mitral stenosis .
- Significant dyspnea.
- Favorable anatomical characteristics for Percutaneous Mitral Commissurotomy as assessed by trans-thoracic echo.
Who cannot join
- Critically ill patients including hemo-dynamically unstable patient.
- Implanted pacemakers/cardiac defibrillators and other electronic implants.
- Cerebral aneurysm clips.
- Pregnancy.
- Significant renal impairment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut medical school
Asyut
Ahmed Abdel Nasser, MBBS, +2001014715052
Amr Elbadry, MD, +2001060701601
About this study
Official title: Detection of Left Atrial Thrombus by Cardiac Magnetic Resonance in Patients Undergoing Percutaneous Mitral Commissurotomy
The incidence of rheumatic heart diseases have not declined in our population .Rheumatic heart diseases, often neglected by media and policy makers, is a major burden in developing countries where it causes most of the cardiovascular morbidity and mortality in young people, leading to about 250000 deaths per year worldwide. Mitralstenosis is one of the most common complications of rheumatic heart diseases in our community. A treatment of choice in suitable cases is percutaneous Mitral Commissurotomy .Preoperative evaluation for Percutaneous Mitral Commissurotomy typically requires trans-esophageal echocardiogram (TEE) for the presence of LA thrombus. TEE is currently considered the gold standard for LA thrombus detection given its favorable sensitivity and specificity . With recent advances,CMRis now becoming another reliable diagnostic method for evaluation of thrombus in the left atrium, particularly when delayed imaging is performed.
Whereas TEE is a semi-invasive procedure, CMRis totally non-invasive . Effectiveness of left ventricular thrombus detection by CMR has been validated, and it is now becoming a preferred imaging modality for evaluation of left ventricular thrombus . Moreover, in patients undergoing pulmonary vein isolation,Cardiac Magnetic Resonance was validated against TEE for LA \& left atrial appendage . To our knowledge, there are few data regarding the utility of Cardiac Magnetic Resonance for detection of LA thrombus in patients undergoing Percutaneous Mitral Commissurotomy.
Read the detailed description
Patients with Mitral stenosis that admitted in Assiut University hospital -Cardiovascular Department for doing Percutaneous Mitral Commissurotomy Will undergo Trans-esophageal echo and Cardiac Magnetic Resonance for detection of left atrial Thrombus and left atrial appendage thrombus. Investigators will compare the result of Cardiac Magnetic Resonance with the results of Trans-esophageal echo for seen the sensitivity and specificity of Cardiac Magnetic Resonance in compare to Trans-esophageal echo who is the gold standard imaging for detection of left atrial and left atrial appendage Thrombus.Data will be presented as mean ± standard deviation for continuous variables and frequency for categorical variables.
- Patients with and without thrombus will be compared using independent (unpaired) Student t test for continuous variables and the Fisher exact test for categorical variables, or their non-parametric equivalents, after testing the data for normality.
- Diagnostic performance of each CMR component will be calculated in the standard manner.
- Conditions
- Left Atrial Thrombosis
- Being tested
- Cardiac Magnetic Resonance, Trans-esophageal echo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic ResonanceRadiation
Imaging modality used to detection thrombus in left atrium
Trans-esophageal echoRadiation
a procedure in which the ultrasound probe is inserted into the esophagus and ultrasonographic images are obtained of the heart using echo and color Doppler images.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Magnetic Resonance &Trans-esophageal echo | Other | patients undergo Percutaneous Mitral Commissurotomy will do cardiac magnetic resonance and trans esophageal echo for detection of left atrial thrombus Receives: Radiation: Cardiac Magnetic Resonance; Radiation: Trans-esophageal echo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity of Cardiac Magnetic Resonance against Trans-esophageal echo
true positive rate or probability of detection and true negative rate
Measured: 24 hours
Secondary outcomes (1)
positive & negative predictive values, accuracy of Cardiac Magnetic Resonance against Trans-esophageal echo
- Positive predictive value is the probability that subjects with a positive screening test truly have the disease. Negative predictive value is the probability that subjects with a negative screening test truly don't have the disease
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study startApr 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial ThrombosisStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Nasser Badr Hamdan, Assiut University
- Investigators
- Amr Elbadry, MD, Principal investigator, assiut medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662880
- Sponsor's protocol ID
- C.M.R
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Left Atrial Thrombus by Cardiac Magnetic Resonance in Patients Undergoing Percutaneous Mitral Commissurotomy
- ClinicalTrials.gov ID
- NCT03662880
- Acronym / sponsor ID
- C.M.R
- Conditions
- Left Atrial Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 10 Sep 2018 (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.
The incidence of rheumatic heart diseases have not declined in our population .Rheumatic heart diseases, often neglected by media and policy makers, is a major burden in developing countries where it causes most of the cardiovascular morbidity and mortality in young people, leading to about 250000 deaths per year worldwide. Mitralstenosis is one of the most common complications of rheumatic heart diseases in our community. A treatment of choice in suitable cases is percutaneous Mitral Commissurotomy .Preoperative evaluation for Percutaneous Mitral Commissurotomy typically requires trans-esophageal echocardiogram (TEE) for the presence of LA thrombus. TEE is currently considered the gold standard for LA thrombus detection given its favorable sensitivity and specificity . With recent advances,CMRis now becoming another reliable diagnostic method for evaluation of thrombus in the left atrium, particularly when delayed imaging is performed.
Whereas TEE is a semi-invasive procedure, CMRis totally non-invasive . Effectiveness of left ventricular thrombus detection by CMR has been validated, and it is now becoming a preferred imaging modality for evaluation of left ventricular thrombus . Moreover, in patients undergoing pulmonary vein isolation,Cardiac Magnetic Resonance was validated against TEE for LA \& left atrial appendage . To our knowledge, there are few data regarding the utility of Cardiac Magnetic Resonance for detection of LA thrombus in patients undergoing Percutaneous Mitral Commissurotomy.
Detailed description
Patients with Mitral stenosis that admitted in Assiut University hospital -Cardiovascular Department for doing Percutaneous Mitral Commissurotomy Will undergo Trans-esophageal echo and Cardiac Magnetic Resonance for detection of left atrial Thrombus and left atrial appendage thrombus. Investigators will compare the result of Cardiac Magnetic Resonance with the results of Trans-esophageal echo for seen the sensitivity and specificity of Cardiac Magnetic Resonance in compare to Trans-esophageal echo who is the gold standard imaging for detection of left atrial and left atrial appendage Thrombus.Data will be presented as mean ± standard deviation for continuous variables and frequency for categorical variables.
- Patients with and without thrombus will be compared using independent (unpaired) Student t test for continuous variables and the Fisher exact test for categorical variables, or their non-parametric equivalents, after testing the data for normality.
- Diagnostic performance of each CMR component will be calculated in the standard manner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Magnetic Resonance &Trans-esophageal echo | Other | Radiation: Cardiac Magnetic Resonance, Radiation: Trans-esophageal echopatients undergo Percutaneous Mitral Commissurotomy will do cardiac magnetic resonance and trans esophageal echo for detection of left atrial thrombus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Severe mitral stenosis .
- Significant dyspnea.
- Favorable anatomical characteristics for Percutaneous Mitral Commissurotomy as assessed by trans-thoracic echo.
Key exclusion criteria (5 listed)
- Critically ill patients including hemo-dynamically unstable patient.
- Implanted pacemakers/cardiac defibrillators and other electronic implants.
- Cerebral aneurysm clips.
- Pregnancy.
- Significant renal impairment
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 |
|---|---|---|
| Cardiac Magnetic ResonanceImaging modality used to detection thrombus in left atrium | Radiation | Cardiac Magnetic Resonance &Trans-esophageal echo |
| Trans-esophageal echoa procedure in which the ultrasound probe is inserted into the esophagus and ultrasonographic images are obtained of the heart using echo and color Doppler images. | Radiation | Cardiac Magnetic Resonance &Trans-esophageal echo |
Primary outcome
Sensitivity, specificity of Cardiac Magnetic Resonance against Trans-esophageal echo
Time frame: 24 hours
true positive rate or probability of detection and true negative rate
1 secondary outcome
positive & negative predictive values, accuracy of Cardiac Magnetic Resonance against Trans-esophageal echo
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- 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.
Amr Elbadry, MD principal investigator
assiut medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance and Trans-esophageal echo in people with Left Atrial Thrombosis, run by Assiut University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Sep 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdel Naseer, MBBS (+2001014715052, ahmedbadr1261990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity of Cardiac Magnetic Resonance against Trans-esophageal echo (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2018.