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Uses of CMR in Detection of Left Atrial Thrombus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662880
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdel Nasser Badr Hamdan, Assiut University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Left Atrial Thrombosis Radiation: Cardiac Magnetic Resonance Radiation: Trans-esophageal echo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Left Atrial Thrombus by Cardiac Magnetic Resonance in Patients Undergoing Percutaneous Mitral Commissurotomy
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Cardiac Magnetic Resonance &Trans-esophageal echo
patients undergo Percutaneous Mitral Commissurotomy will do cardiac magnetic resonance and trans esophageal echo for detection of left atrial thrombus
Radiation: Cardiac Magnetic Resonance
Imaging modality used to detection thrombus in left atrium

Radiation: Trans-esophageal echo
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. positive & negative predictive values, accuracy of Cardiac Magnetic Resonance against Trans-esophageal echo [ Time Frame: 4 months ]
    - 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe mitral stenosis .
  • Significant dyspnea.
  • Favorable anatomical characteristics for Percutaneous Mitral Commissurotomy as assessed by trans-thoracic echo.

Exclusion criteria:

  • Critically ill patients including hemo-dynamically unstable patient.
  • Implanted pacemakers/cardiac defibrillators and other electronic implants.
  • Cerebral aneurysm clips.
  • Pregnancy.
  • Significant renal impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662880


Contacts
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Contact: Ahmed Abdel Naseer, MBBS +2001014715052 ahmedbadr1261990@gmail.com

Locations
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Egypt
Assiut medical school
Assiut, Egypt
Contact: Ahmed Abdel Nasser, MBBS    +2001014715052      
Contact: Amr Elbadry, MD    +2001060701601      
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Amr Elbadry, MD assiut medical school
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Responsible Party: Ahmed Abdel Nasser Badr Hamdan, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03662880    
Other Study ID Numbers: C.M.R
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases