Uses of CMR in Detection of Left Atrial Thrombus

Left Atrial Thrombosis Clinical Trial

Official title:

Detection of Left Atrial Thrombus by Cardiac Magnetic Resonance in Patients Undergoing Percutaneous Mitral Commissurotomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03662880
• Other study ID #: C.M.R
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: April 2022

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: Ahmed Abdel Naseer, MBBS
• Phone: +2001014715052
• Email: ahmedbadr1261990[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Left Atrial Thrombosis
• Thrombosis

Intervention

Radiation:
• Cardiac Magnetic Resonance
Imaging modality used to detection thrombus in left atrium
• 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.

Locations

Country	Name	City	State
Egypt	Assiut medical school	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity of Cardiac Magnetic Resonance against Trans-esophageal echo	true positive rate or probability of detection and true negative rate	24 hours
Secondary	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	4 months