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

• ClinicalTrials.gov Identifier: NCT01755806
• Recruitment Status: Completed
• First Posted: December 24, 2012
• Last Update Posted: December 24, 2012
• Sponsor: Modarres Hospital
• 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.

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

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