Clinical Trials Directory

Trials / Completed

CompletedNCT06311071

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
Phase
Study type
Observational
Enrollment
498 (actual)
Sponsor
Shiraz University of Medical Sciences · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTcalcium scoreCalcium score of coronaries obtained fro coronary CT angiography
DIAGNOSTIC_TESTInvasive coronary angiographyInvasive coronary angiography from radial artery with contrast injection

Timeline

Start date
2022-01-01
Primary completion
2023-05-01
Completion
2023-09-01
First posted
2024-03-15
Last updated
2024-03-22

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT06311071. Inclusion in this directory is not an endorsement.