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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Modarres Hospital
ClinicalTrials.gov Identifier:
NCT01755806
First received: December 17, 2012
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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
Aortic Valve Calcification

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Modarres Hospital:

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 [ Time Frame: during a few heat beat (8 to 13 seconds) ] [ Designated as safety issue: No ]
    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


Enrollment: 104
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
aortic root dimension change
those without aortic valve calcification
aortic root dimension change, aortic valve calcium score
those with 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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients referring for coronary CT angiography

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01755806

Locations
Iran, Islamic Republic of
Modarres Hospital
Tehran, Iran, Islamic Republic of, 19998734383
Rajaie Cardiovascular medical and Research Center
Tehran, Iran, Islamic Republic of
Day General Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Modarres Hospital
  More Information

No publications provided by Modarres Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Modarres Hospital
ClinicalTrials.gov Identifier: NCT01755806     History of Changes
Other Study ID Numbers: ModarresH_001
Study First Received: December 17, 2012
Last Updated: December 21, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Modarres Hospital:
Aortic annulus
Aortic calcification
Multislice computed tomography
Cardiac cycle

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014