Uses of CMR in Detection of Left Atrial Thrombus

NCT03662880 | Unknown

• 1 other identifier: C.M.R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Atrial Thrombosis

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity of Cardiac Magnetic Resonance against Trans-esophageal echo

  true positive rate or probability of detection and true negative rate

  24 hours

Secondary Outcomes (1)

• positive & negative predictive values, accuracy of Cardiac Magnetic Resonance against Trans-esophageal echo

  4 months

Study Arms (1)

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

Radiation: Cardiac Magnetic Resonance; Radiation: Trans-esophageal echo

Interventions

Cardiac Magnetic Resonance RADIATION

Imaging modality used to detection thrombus in left atrium

Cardiac Magnetic Resonance &Trans-esophageal echo

Trans-esophageal echo 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.

Cardiac Magnetic Resonance &Trans-esophageal echo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut medical school

Asyut, Egypt

Location

Study Officials

• Amr Elbadry, MD

  assiut medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdel Naseer, MBBS

CONTACT

+2001014715052; ahmedbadr1261990@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)