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The Predictive Value of Coronary Artery Calcium Score

The Utility of Coronary Artery Calcium Score for the Prediction of Coronary Artery Disease in Patients With Cardiac Symptoms; a Diagnostic Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06311071
Enrollment
498
Registered
2024-03-15
Start date
2022-01-01
Completion date
2023-09-01
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, coronary calcium score, cardiovascular risk score

Brief 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. 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

Interventions

DIAGNOSTIC_TESTcalcium score

Calcium score of coronaries obtained fro coronary CT angiography

Invasive coronary angiography from radial artery with contrast injection

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* Previously diagnosed coronary artery disease * Cerebrovascular accident (CVA) * Peripheral artery disease * Pregnancy * Medical instability * Hypersensitivity to contrast materials * Having atrial fibrillation

Design outcomes

Primary

MeasureTime frameDescription
coronary artery disease1 yearstenosis more than 50% in selective coronary angiography
coronary calcium score1 yearcalcium score obtained from coronary CT angiography, 0 no risk, 0-100 low risk, more than 100 high risk

Secondary

MeasureTime frameDescription
cardiovascular risk score1 yearcardiovascular risk score obtained from Framingham risk score, low risk if less than 10%, moderate risk 10-20% and high risk if more than 20%

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026