Coronary Artery CalcificationNCT01158066
Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification
A study testing CT Cardiac in people with Coronary Artery Calcification, run by Ziv Hospital at 1 site in Israel.
Trial summary
Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Coronary Artery Calcification
- What is being tested?
- CT Cardiac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Mar 2012
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD
Who cannot join
- Patients with PCI or CABG will be excluded
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv medical center liver unit
Safed, Israel, 13100
Nimer Assy, MD, +972-46828445, assy.n@ziv.health.gov.il
About this study
Official title: Association Between NAFLD and Coronary Artery Calcification
Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial
Read the detailed description
Coronary artery disease are 8 times more prevalent in patients with NAFLD that the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial. AIM: the aim is to evaluate the association between CAC score ( CT) and NAFLD (CT). the working hypothesis is that Beside the traditional risk factors including age, diabetes, NAFLD is also associated with moderate to high risk of CAD.
- Conditions
- Coronary Artery Calcification
- Being tested
- CT Cardiac
- Keywords
- NAFLD, Calcium score, Liver Fat, Visceral fat, excessive visceral fat, excessive liver fat accumulation, Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT CardiacProcedure or surgery
the patient will undergo cardiac CT
| Study group | Role | What they receive |
|---|---|---|
| CT cardiac | No intervention | the patient will undergo cardiac CT Receives: Procedure: CT Cardiac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total calcium score measurement
total calcium score will be measured
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startAug 2011
- Primary completionJan 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158066
- Sponsor's protocol ID
- NAFLD and CAC
- Status last verified
- Jun 2010
- First submitted
- 4 Jul 2010
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between NAFLD and Coronary Artery Calcification
- ClinicalTrials.gov ID
- NCT01158066
- Acronym / sponsor ID
- NAFLD and CAC
- Conditions
- Coronary Artery Calcification
- Keywords
- NAFLD, Calcium score, Liver Fat, Visceral fat, excessive visceral fat, excessive liver fat accumulation, Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 8 Jul 2010 (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.
Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial
Detailed description
Coronary artery disease are 8 times more prevalent in patients with NAFLD that the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial. AIM: the aim is to evaluate the association between CAC score ( CT) and NAFLD (CT). the working hypothesis is that Beside the traditional risk factors including age, diabetes, NAFLD is also associated with moderate to high risk of CAD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT cardiac | No intervention | Procedure: CT Cardiacthe patient will undergo cardiac CT |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD
Key exclusion criteria (1 listed)
- Patients with PCI or CABG will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Cardiacthe patient will undergo cardiac CT | Procedure or surgery | CT cardiac |
Primary outcome
Total calcium score measurement
Time frame: 1 month
total calcium score will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Cardiac in people with Coronary Artery Calcification, run by Ziv Hospital at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assy Nimer, MD (+97246828445, assy.n@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total calcium score measurement (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2011.