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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01755806

Recruitment Status : Completed

First Posted : December 24, 2012

Last Update Posted : December 24, 2012

Sponsor:

Information provided by (Responsible Party):

Modarres Hospital

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
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

Layout table for study information

Study Type :	Observational
Actual Enrollment :	104 participants
Observational Model:	Case-Control
Time Perspective:	Retrospective
Study Start Date :	January 2012
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Supravalvular aortic stenosis

MedlinePlus related topics: Minerals

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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 [ 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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	20 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755806

Locations

Layout table for location information

Iran, Islamic Republic of
Modarres Hospital
Tehran, Iran, Islamic Republic of, 19998734383
Day General Hospital
Tehran, Iran, Islamic Republic of
Rajaie Cardiovascular medical and Research Center
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Modarres Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arjmand Shabestari A, Pourghorban R, Tehrai M, Pouraliakbar H, Faghihi Langroudi T, Bakhshandeh H, Abdi S. 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. Int J Cardiovasc Imaging. 2013 Aug;29(6):1391-400. doi: 10.1007/s10554-013-0217-7. Epub 2013 Apr 13.

Layout table for additonal information

Responsible Party:	Modarres Hospital
ClinicalTrials.gov Identifier:	NCT01755806
Other Study ID Numbers:	ModarresH_001
First Posted:	December 24, 2012 Key Record Dates
Last Update Posted:	December 24, 2012
Last Verified:	December 2012

Keywords provided by Modarres Hospital:


Aortic annulus Aortic calcification Multislice computed tomography Cardiac cycle

Additional relevant MeSH terms:

Layout table for MeSH terms

Aortic Valve Stenosis Calcinosis Calcium Metabolism Disorders Metabolic Diseases	Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction

To Top