Coronary Artery DiseaseNCT06311071
The Predictive Value of Coronary Artery Calcium Score
An observational study of Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- calcium score and Invasive coronary angiography
- Type of treatment
- Injection or infusion
- How many people
- 498 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2022to 1 Sep 2023
- How long will I take part?
- 365 Days
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with any cardiac symptoms with positive noninvasive tests referred to cardiology clinic with positive non invasive tests like exercise test or echocardiography or perfusion cardiac scan
Who may be able to join
- Age over 40 years, having cardiovascular symptoms (including chest pain, dyspnea on exertion, etc.), and positive primary non-invasive tests, such as myocardial perfusion imaging (MPI) or exercise tolerance test (ETT)
Who cannot join
- Previously diagnosed coronary artery disease
- Cerebrovascular accident (CVA)
- Peripheral artery disease
- Pregnancy
- Medical instability
- Hypersensitivity to contrast materials
- Having atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of Coronary Artery Calcium Score for the Prediction of Coronary Artery Disease in Patients With Cardiac Symptoms; a Diagnostic Study
In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients
Read the detailed description
In this prospective study 498 patient who referred to cardiology clinic with any cardiac symptoms and positive noninvasive tests without preestablished coronary artery disease ( CAD), were enrolled. All the patients underwent coronary artery calcium score (CACS) testing, and total calcium scores were recorded. A calcium score of zero was considered as having very low risk for CAD. A score of 1 to 99 was defined as having low risk, 101 to 299 as having intermediate risk, and 400 or more as having high risk for CAD. Then, invasive (conventional) coronary angiography by radial access, as the gold standard for the diagnosis of CAD, was performed for all of the involved participants.
Coronary artery stenosis equal to or more than 50% was considered as a significant narrowing [25]. Patients with at least one diseased coronary artery with a significant narrowing were considered to have CAD. Minor branches were considered only if their main supplying branch was not diseased. A group of expert interventional cardiologists performed and reported coronary angiographies. The study was single-blind; cardiologists were unaware of the results of CAC scores when performing conventional coronary angiographies
- Conditions
- Coronary Artery Disease
- Being tested
- calcium score, Invasive coronary angiography
- Keywords
- coronary artery disease, coronary calcium score, cardiovascular risk score
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium scoreDiagnostic test
Also called CAC score
Calcium score of coronaries obtained fro coronary CT angiography
Invasive coronary angiographyDiagnostic test
Invasive coronary angiography from radial artery with contrast injection
| Study group | Role | What they receive |
|---|---|---|
| patient group | patient suspected to have coronary artery disease in noninvasive tests Receives: Diagnostic Test: calcium score; Diagnostic Test: Invasive coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary artery disease
stenosis more than 50% in selective coronary angiography
Measured: 1 year
coronary calcium score
calcium score obtained from coronary CT angiography, 0 no risk, 0-100 low risk, more than 100 high risk
Measured: 1 year
Secondary outcomes (1)
cardiovascular risk score
cardiovascular risk score obtained from Framingham risk score, low risk if less than 10%, moderate risk 10-20% and high risk if more than 20%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2022
- Primary completion1 May 2023
- Study completion1 Sep 2023
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 Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 498 participants (actual)
- Target duration
- 365 Days
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311071
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1401.200
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is available in registry and will be available on rational request
Publications
Dindari M, Mehdizadeh Parizi MJ, Golchin Vafa R, Heydarzadeh R, Zarifkar H, Zarifkar H, Zarifkar H, Hosseini N, Montaseri M, Kojuri J. Utilizing the coronary artery calcium score to predict coronary artery disease in individuals with presumed cardiac symptoms: A diagnostic study. Am Heart J Plus. 2026 Mar 7;64:100745. doi: 10.1016/j.ahjo.2026.100745. eCollection 2026 Apr.
PubMed 41853616
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Coronary Artery Calcium Score for the Prediction of Coronary Artery Disease in Patients With Cardiac Symptoms; a Diagnostic Study
- ClinicalTrials.gov ID
- NCT06311071
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1401.200
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, coronary calcium score, cardiovascular risk score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- 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.
In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients
Detailed description
In this prospective study 498 patient who referred to cardiology clinic with any cardiac symptoms and positive noninvasive tests without preestablished coronary artery disease ( CAD), were enrolled. All the patients underwent coronary artery calcium score (CACS) testing, and total calcium scores were recorded. A calcium score of zero was considered as having very low risk for CAD. A score of 1 to 99 was defined as having low risk, 101 to 299 as having intermediate risk, and 400 or more as having high risk for CAD. Then, invasive (conventional) coronary angiography by radial access, as the gold standard for the diagnosis of CAD, was performed for all of the involved participants.
Coronary artery stenosis equal to or more than 50% was considered as a significant narrowing [25]. Patients with at least one diseased coronary artery with a significant narrowing were considered to have CAD. Minor branches were considered only if their main supplying branch was not diseased. A group of expert interventional cardiologists performed and reported coronary angiographies. The study was single-blind; cardiologists were unaware of the results of CAC scores when performing conventional coronary angiographies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 365 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Diagnostic Test: calcium score, Diagnostic Test: Invasive coronary angiographypatient suspected to have coronary artery disease in noninvasive tests |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with any cardiac symptoms with positive noninvasive tests referred to cardiology clinic with positive non invasive tests like exercise test or echocardiography or perfusion cardiac scan
Key inclusion criteria (1 listed)
- Age over 40 years, having cardiovascular symptoms (including chest pain, dyspnea on exertion, etc.), and positive primary non-invasive tests, such as myocardial perfusion imaging (MPI) or exercise tolerance test (ETT)
Key exclusion criteria (7 listed)
- Previously diagnosed coronary artery disease
- Cerebrovascular accident (CVA)
- Peripheral artery disease
- Pregnancy
- Medical instability
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 |
|---|---|---|
| calcium scoreAlso: CAC scoreCalcium score of coronaries obtained fro coronary CT angiography | Diagnostic test | patient group |
| Invasive coronary angiographyInvasive coronary angiography from radial artery with contrast injection | Diagnostic test | patient group |
Primary outcome
coronary artery disease
Time frame: 1 year
stenosis more than 50% in selective coronary angiography
coronary calcium score
Time frame: 1 year
calcium score obtained from coronary CT angiography, 0 no risk, 0-100 low risk, more than 100 high risk
1 secondary outcome
cardiovascular risk score
Time frame: 1 year
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 22 Mar 2024.
- Derived from this study: PubMed 41853616Dindari M, Mehdizadeh Parizi MJ, Golchin Vafa R, Heydarzadeh R, Zarifkar H, Zarifkar H, Zarifkar H, Hosseini N, Montaseri M, Kojuri J. Utilizing the coronary artery calcium score to predict coronary artery disease in individuals with presumed cardiac symptoms: A diagnostic study. Am Heart J Plus. 2026 Mar 7;64:100745. doi: 10.1016/j.ahjo.2026.100745. eCollection 2026 Apr.
- Individual participant dataSharing planned: No. The data is available in registry and will be available on rational request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site 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 7 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 22 Mar 2024. 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 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?
coronary artery disease (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06311071, 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 22 Mar 2024.