The Predictive Value of Coronary Artery Calcium Score

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06311071
• Other study ID #: IR.SUMS.MED.REC.1401.200
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2024
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: September 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• calcium score
Calcium score of coronaries obtained fro coronary CT angiography
• Invasive coronary angiography
Invasive coronary angiography from radial artery with contrast injection

Locations

Country	Name	City	State
Iran, Islamic Republic of	Javad Kojuri	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coronary artery disease	stenosis more than 50% in selective coronary angiography	1 year
Primary	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	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