Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Silent Atrial Fibrillation in Patients With Mitral Stenosis and Sinus Rhythm and Its Correlation Left Atrial Thrombus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03505073
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Sabry, Assiut University

Brief Summary:
Detection of Prevalence of silent atrial fibrillation in patients with Mitral stenosis and sinus rhythm and its correlation with the presence of left atrial thrombus.

Condition or disease Intervention/treatment
Atrial Fibrillation Left Atrial Thrombosis Mitral Valve Stenosis Device: 12 lead electrocardiogram Device: Holter Monitor Device: Transthoracic echocardiogram Device: Transesophageal echocardiogram

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prevalence of Silent Atrial Fibrillation in Patients With Mitral Stenosis and Sinus Rhythm and Its Correlation With the Presence of Left Atrial Thrombus
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: 12 lead electrocardiogram
    A device recording the electrical activity of the heart over a period of time using electrodes placed on the skin.
  • Device: Holter Monitor
    A type of ambulatory electrocardiography device, a portable device for cardiac monitoring (the monitoring of the electrical activity of the cardiovascular system) for at least 24 to 48 hours (often for two weeks at a time).
  • Device: Transthoracic echocardiogram
    A standard echocardiogram or cardiac ultrasound in which the echocardiography transducer (or probe) is placed on the chest wall (or thorax) of the subject, and images are taken through the chest wall. This is a noninvasive, highly accurate, and quick assessment of the overall health of the heart.
  • Device: Transesophageal echocardiogram
    An alternative way to perform an echocardiogram. A specialized probe containing an ultrasound transducer at its tip is passed into the patient's esophagus. This allows image and Doppler evaluation from a location directly behind the heart.


Primary Outcome Measures :
  1. Detection of prevalence of silent atrial fibrillation in patients with Mitral stenosis and sinus rhythm and its correlation with the presence of left atrial thrombus. [ Time Frame: 1 Year ]
    Detection of prevalence of silent atrial fibrillation in patients with Mitral stenosis and sinus rhythm and its correlation with the presence of left atrial thrombus.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients meeting the inclusion criteria will be collected from Assiut university hospital.
Criteria

Inclusion Criteria:

  • All patients have significant Mitral valve stenosis with baseline sinus rhythm.

Exclusion Criteria:

  • Patients suffering from Mitral valve stenosis with previously confirmed any type of atrial fibrillation.

Additional Information:

Layout table for additonal information
Responsible Party: Eman Sabry, Assiut - Egypt, Assiut University
ClinicalTrials.gov Identifier: NCT03505073     History of Changes
Other Study ID Numbers: 10256
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Constriction, Pathologic
Thrombosis
Mitral Valve Stenosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Embolism and Thrombosis
Vascular Diseases
Heart Valve Diseases