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

Aortic Valve Calcification Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755806
• Other study ID #: ModarresH_001
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: December 21, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Modarres Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aortic Valve Calcification
• Aortic Valve Stenosis
• Calcinosis

Locations

Country	Name	City	State
Iran, Islamic Republic of	Day General Hospital	Tehran
Iran, Islamic Republic of	Modarres Hospital	Tehran
Iran, Islamic Republic of	Rajaie Cardiovascular medical and Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Modarres Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No