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Assessment of Left Ventricular Torsion by Echocardiography Study (LVTorsion)

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ClinicalTrials.gov Identifier: NCT00589836
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Zoran Popovic, The Cleveland Clinic

Study Type: Observational
Study Design: Observational Model: Case-Control;   Time Perspective: Cross-Sectional
Condition: Hypertrophic Cardiomyopathy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Consecutive patients with clinically indicated MRI and previous satisfactory echocardiographic images on a previously performed study had a research echocardiographic study on the same day as the MRI

Reporting Groups
  Description
Cardiac Pathologies Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.

Participant Flow:   Overall Study
    Cardiac Pathologies
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cardiac Pathologies Patients with cardiac pathologies of aortic root disorder, severe aortic stenosis, severe aortic insufficiency, aortic valve replacement, ischemic heart disease and cardiomyopathies had tissue DTI and MRI performed

Baseline Measures
   Cardiac Pathologies 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   8 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  15.0% 
Male      17  85.0% 


  Outcome Measures

1.  Primary:   Accuracy of Doppler Tissue Imaging   [ Time Frame: 1 1/2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Zoran Popovic MD
Organization: Cleveland Clinic
phone: 216 444-9242
e-mail: popoviz@ccf.org



Responsible Party: Zoran Popovic, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00589836     History of Changes
Other Study ID Numbers: IRB 05-023
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: April 20, 2017
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018