The Predictive Value of Coronary Artery Calcium Score

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: calcium score; Diagnostic Test: Invasive coronary angiography

• Registration Number: NCT06311071
• Lead Sponsor: Shiraz University of Medical Sciences

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

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-09-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient group	calcium score	patient suspected to have coronary artery disease in noninvasive tests
patient group	Invasive coronary angiography	patient suspected to have coronary artery disease in noninvasive tests

Primary Outcome Measures

Name	Time	Method
coronary calcium score	1 year	calcium score obtained from coronary CT angiography, 0 no risk, 0-100 low risk, more than 100 high risk
coronary artery disease	1 year	stenosis more than 50% in selective coronary angiography

Secondary Outcome Measures

Name	Time	Method
cardiovascular risk score	1 year	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%

Trial Locations

Locations (1)

Javad Kojuri; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of