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Comparison of Aortic Root Dimension Changes During Cardiac Cycle Between the Patients With and Without Aortic Valve Calcification Using ECG-gated 64-slice and Dual-source 256-slice Computed Tomography Scanners: Results of a Multicenter Study

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ClinicalTrials.gov Identifier: NCT01755806
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Modarres Hospital

Tracking Information
First Submitted Date December 17, 2012
First Posted Date December 24, 2012
Last Update Posted Date December 24, 2012
Study Start Date January 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2012)
Evidence of aortic root dimension change confirmed by multislice CT in systolic phase (30% of R-R interval) compared to diastolic phase (70% of R-R interval) after retrospective ECG gating [ Time Frame: during a few heat beat (8 to 13 seconds) ]
Detailed information about aortic root dimension changes during cardiac cycle has become of utmost interest especially after introduction of transcatheter aortic valve implantation (TAVI) as an alternative therapeutic procedure in patients with severe aortic stenosis, in that paravalvular regurgitation and procedural failure will ensue from errors in selecting the appropriate prosthesis size
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Aortic Root Dimension Changes During Cardiac Cycle Between the Patients With and Without Aortic Valve Calcification Using ECG-gated 64-slice and Dual-source 256-slice Computed Tomography Scanners: Results of a Multicenter Study
Official Title Not Provided
Brief Summary This study seeks to compare aortic dimension changes during cardiac cycle in patients with and without aortic valve calcification and to evaluate its correlation with aortic valve calcium score in former group.
Detailed Description The study population comprised 104 patients referred to three cardiac imaging centers for coronary multislice computed tomography, including 52 patients with aortic valve calcification as the study group and 52 subjects without evidence of calcification in their aortic valve, who served as a control group. Data were reconstructed at each 10% of RR-interval during the cardiac cycle and reconstructed images at 30-35% and 70-75% of R-R intervals were obtained, representing systole and diastole, respectively. For diastolic phase, in most cases images at 70% were acquired. Thereafter, acquired images were transferred to a single remote workstation for post-processing and subsequent off-line analysis.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients referring for coronary CT angiography
Condition Aortic Valve Calcification
Intervention Not Provided
Study Groups/Cohorts
  • aortic root dimension change
    those without aortic valve calcification
  • aortic root dimension change, aortic valve calcium score
    those with aortic valve calcification
Publications * Arjmand Shabestari A, Pourghorban R, Tehrai M, Pouraliakbar H, Faghihi Langroudi T, Bakhshandeh H, Abdi S. Comparison of aortic root dimension changes during cardiac cycle between the patients with and without aortic valve calcification using ECG-gated 64-slice and dual-source 256-slice computed tomography scanners: results of a multicenter study. Int J Cardiovasc Imaging. 2013 Aug;29(6):1391-400. doi: 10.1007/s10554-013-0217-7. Epub 2013 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2012)
104
Original Actual Enrollment Same as current
Actual Study Completion Date December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- Patients referring for multislice coronary computed tomography for any reason

Exclusion Criteria:

  • Arrhythmia
  • Hypertrophic cardiomyopathy
  • Aneurysm formation of ascending aorta
  • Marfan's disease
  • Ehlers-Danlos syndrome
  • History of coronary artery bypass surgery
  • History of coronary stenting
  • Aortic valve surgery
  • Thoracic aorta surgery
  • Aortic valve stenosis
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01755806
Other Study ID Numbers ModarresH_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Modarres Hospital
Study Sponsor Modarres Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Modarres Hospital
Verification Date December 2012