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
1 other identifier
observational
104
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedDecember 24, 2012
December 1, 2012
10 months
December 17, 2012
December 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
during a few heat beat (8 to 13 seconds)
Study Arms (2)
aortic root dimension change
those without aortic valve calcification
aortic root dimension change, aortic valve calcium score
those with aortic valve calcification
Eligibility Criteria
patients referring for coronary CT angiography
You may qualify if:
- \- Patients referring for multislice coronary computed tomography for any reason
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Modarres Hospital
Tehran, 19998734383, Iran
Day General Hospital
Tehran, Iran
Rajaie Cardiovascular medical and Research Center
Tehran, Iran
Related Publications (1)
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.
PMID: 23584562DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 24, 2012
Study Start
January 1, 2012
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
December 24, 2012
Record last verified: 2012-12