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Clinical Trials/NCT01755806
NCT01755806
Completed
Not Applicable

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

Modarres Hospital3 sites in 1 country104 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Calcification
Sponsor
Modarres Hospital
Enrollment
104
Locations
3
Primary Endpoint
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
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Modarres Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Study Sites (3)

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