Uses of CMR in Detection of Left Atrial Thrombus

• ClinicalTrials.gov Identifier: NCT03662880
• Recruitment Status: Not yet recruiting
• First Posted: September 10, 2018
• Last Update Posted: September 10, 2018
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ahmed Abdel Nasser Badr Hamdan, Assiut University

Tracking Information

• First Submitted Date: September 6, 2018
• First Posted Date: September 10, 2018
• Last Update Posted Date: September 10, 2018
• Estimated Study Start Date: April 2019
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2018)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 7, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Uses of CMR in Detection of Left Atrial Thrombus
• Official Title: Detection of Left Atrial Thrombus by Cardiac Magnetic Resonance in Patients Undergoing Percutaneous Mitral Commissurotomy

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Left Atrial Thrombosis

Intervention

• 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.

Study Arms

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

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 7, 2018): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03662880
• Other Study ID Numbers: C.M.R
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Ahmed Abdel Nasser Badr Hamdan, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Amr Elbadry, MD; assiut medical school

• PRS Account: Assiut University
• Verification Date: September 2018