Aortic Valve CalcificationNCT01755806
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
An observational study of Aortic Valve Calcification, run by Modarres Hospital at 3 sites in Iran.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Aortic Valve Calcification
- How many people
- 104 participants
- Where
- 3 sitesIran
- Study dates
- Jan 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients referring for coronary CT angiography
Who may be able to join
- Patients referring for multislice coronary computed tomography for any reason
Who cannot join
- Arrhythmia
- Hypertrophic cardiomyopathy
- Aneurysm formation of ascending aorta
- Marfan's disease
- Ehlers-Danlos syndrome
- History of coronary artery bypass surgery
Show all 10Show fewer
- History of coronary stenting
- Aortic valve surgery
- Thoracic aorta surgery
- Aortic valve stenosis
Trial locations and contacts
3 sites in 1 country.
Iran3 sites
Modarres Hospital
Tehran, 19998734383
Day General Hospital
Tehran
Rajaie Cardiovascular medical and Research Center
Tehran
About this study
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.
Read the 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.
- Conditions
- Aortic Valve Calcification
- Keywords
- Aortic annulus, Aortic calcification, Multislice computed tomography, Cardiac cycle
- Medical subject headings
- Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aortic root dimension change | those without aortic valve calcification | |
| aortic root dimension change, aortic valve calcium score | those with aortic valve calcification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during a few heat beat (8 to 13 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modarres Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755806
- Sponsor's protocol ID
- ModarresH_001
- Status last verified
- Dec 2012
- First submitted
- 17 Dec 2012
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23584562
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01755806
- Acronym / sponsor ID
- ModarresH_001
- Conditions
- Aortic Valve Calcification
- Keywords
- Aortic annulus, Aortic calcification, Multislice computed tomography, Cardiac cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Modarres HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aortic root dimension change | – | –those without aortic valve calcification |
| aortic root dimension change, aortic valve calcium score | – | –those with aortic valve calcification |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referring for coronary CT angiography
Key inclusion criteria (1 listed)
- Patients referring for multislice coronary computed tomography for any reason
Key exclusion criteria (10 listed)
- Arrhythmia
- Hypertrophic cardiomyopathy
- Aneurysm formation of ascending aorta
- Marfan's disease
- Ehlers-Danlos syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
- Derived from this study: PubMed 23584562Arjmand 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.
Related trials for Aortic Valve Calcification
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Not yet recruitingObservational study
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
AORTIC VALVE DISEASES, Calcification; Heart
Active, not recruitingPhase 3
Colchicine and Inflammation in Aortic Stenosis
Aortic Valve Disease, Aortic Valve Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Calcification, run by Modarres Hospital at 3 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01755806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2012.