NCT01755806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

10 months

First QC Date

December 17, 2012

Last Update Submit

December 21, 2012

Conditions

Keywords

Aortic annulusAortic calcificationMultislice computed tomographyCardiac cycle

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

aortic root dimension change

those without aortic valve calcification

aortic root dimension change, aortic valve calcium score

those with aortic valve calcification

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients referring for coronary CT angiography

You may qualify if:

  • \- Patients referring for multislice coronary computed tomography for any reason

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Modarres Hospital

Tehran, 19998734383, Iran

Location

Day General Hospital

Tehran, Iran

Location

Rajaie Cardiovascular medical and Research Center

Tehran, Iran

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Aortic Valve, Calcification of

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 24, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations