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

Completed

• Conditions: Aortic Valve Calcification

• Registration Number: NCT01755806
• Lead Sponsor: Modarres Hospital

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-11
• Status Verified: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-21
• Last Update Submitted: 2012-12-21
• Study First Posted: 2012-12-24
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (3)

Modarres Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Day General Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Rajaie Cardiovascular medical and Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of