The Predictive Value of Coronary Artery Calcium Score

NCT ID: NCT06311071

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 498 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-09-01

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

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patient group

patient suspected to have coronary artery disease in noninvasive tests

calcium score

Intervention Type: DIAGNOSTIC_TEST

Calcium score of coronaries obtained fro coronary CT angiography

Invasive coronary angiography

Intervention Type: DIAGNOSTIC_TEST

Invasive coronary angiography from radial artery with contrast injection

Interventions

calcium score

Calcium score of coronaries obtained fro coronary CT angiography

Intervention Type: DIAGNOSTIC_TEST

Invasive coronary angiography

Invasive coronary angiography from radial artery with contrast injection

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CAC score

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Javad Kojuri

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Javad Kojuri

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

IR.SUMS.MED.REC.1401.200

Identifier Type: -

Identifier Source: org_study_id