Clinical trial NCT01755806: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Calcification
Keywords: Aortic annulus
Aortic calcification
Multislice computed tomography
Cardiac cycle
Lead sponsor: Modarres Hospital
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients referring for coronary CT angiography

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.

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

Primary outcomes:
measure: 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
timeFrame: during a few heat beat (8 to 13 seconds)
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Modarres Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Day General Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaie Cardiovascular medical and Research Center
Study officials:
References:
citation: 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.