Uses of CMR in Detection of Left Atrial Thrombus

NCT ID: NCT03662880

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2022-04-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Cardiac Magnetic Resonance

Intervention Type: RADIATION

Imaging modality used to detection thrombus in left atrium

Trans-esophageal echo

Intervention Type: RADIATION

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.

Interventions

Cardiac Magnetic Resonance

Imaging modality used to detection thrombus in left atrium

Intervention Type: 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.

Intervention Type: RADIATION

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdel Nasser Badr Hamdan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr Elbadry, MD

Role: PRINCIPAL_INVESTIGATOR

assiut medical school

Locations

Assiut medical school

Asyut, , Egypt

Countries

Egypt

Central Contacts

Ahmed Abdel Naseer, MBBS

Role: CONTACT

ahmedbadr1261990@gmail.com

+2001014715052

Facility Contacts

Ahmed Abdel Nasser, MBBS

Role: primary

+2001014715052

Amr Elbadry, MD

Role: backup

+2001060701601

Other Identifiers

C.M.R

Identifier Type: -

Identifier Source: org_study_id