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Uses of CMR in Detection of Left Atrial Thrombus

Primary Purpose

Left Atrial Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance
Trans-esophageal echo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Left Atrial Thrombosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut medical school

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cardiac Magnetic Resonance &Trans-esophageal echo

Arm Description

patients undergo Percutaneous Mitral Commissurotomy will do cardiac magnetic resonance and trans esophageal echo for detection of left atrial thrombus

Outcomes

Primary Outcome Measures

Sensitivity, specificity of Cardiac Magnetic Resonance against Trans-esophageal echo
true positive rate or probability of detection and true negative rate

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2018
Last Updated
September 7, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03662880
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Atrial Thrombosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Magnetic Resonance &Trans-esophageal echo
Arm Type
Other
Arm Description
patients undergo Percutaneous Mitral Commissurotomy will do cardiac magnetic resonance and trans esophageal echo for detection of left atrial thrombus
Intervention Type
Radiation
Intervention Name(s)
Cardiac Magnetic Resonance
Intervention Description
Imaging modality used to detection thrombus in left atrium
Intervention Type
Radiation
Intervention Name(s)
Trans-esophageal echo
Intervention Description
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 Measure Information:
Title
Sensitivity, specificity of Cardiac Magnetic Resonance against Trans-esophageal echo
Description
true positive rate or probability of detection and true negative rate
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
positive & negative predictive values, accuracy of Cardiac Magnetic Resonance against Trans-esophageal echo
Description
- 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
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdel Naseer, MBBS
Phone
+2001014715052
Email
ahmedbadr1261990@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Elbadry, MD
Organizational Affiliation
assiut medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut medical school
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdel Nasser, MBBS
Phone
+2001014715052
First Name & Middle Initial & Last Name & Degree
Amr Elbadry, MD
Phone
+2001060701601

12. IPD Sharing Statement

Plan to Share IPD
No

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Uses of CMR in Detection of Left Atrial Thrombus

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