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

Sponsor

Modarres Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01755806

Collaborator

(none)

104

Enrollment

Locations

Duration (Months)

34.7

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Calcification

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 Design

Study Type:

Observational

Actual Enrollment :

104 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
aortic root dimension change those without aortic valve calcification
aortic root dimension change, aortic valve calcium score those with aortic valve calcification

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Modarres Hospital	Tehran	Iran, Islamic Republic of	19998734383
2	Day General Hospital	Tehran	Iran, Islamic Republic of
3	Rajaie Cardiovascular medical and Research Center	Tehran	Iran, Islamic Republic of