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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: calcium score; Diagnostic test: Invasive coronary angiography

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 Type: Observational
• Enrollment (Actual): 498

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of, 7134814336
      • Javad Kojuri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient group; patient suspected to have coronary artery disease in noninvasive tests	Diagnostic test: calcium score; Calcium score of coronaries obtained fro coronary CT angiography; Other Names: CAC score; Diagnostic test: Invasive coronary angiography; Invasive coronary angiography from radial artery with contrast injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	1 year

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: coronary artery disease; coronary calcium score; cardiovascular risk score
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: IR.SUMS.MED.REC.1401.200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is available in registry and will be available on rational request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No