Clinical trial NCT06311071: The Predictive Value of Coronary Artery Calcium Score
Official title: The Utility of Coronary Artery Calcium Score for the Prediction of Coronary Artery Disease in Patients With Cardiac Symptoms; a Diagnostic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
coronary calcium score
cardiovascular risk score
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 498
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: coronary artery disease
timeFrame: 1 year
measure: coronary calcium score
timeFrame: 1 year
Secondary outcomes:
measure: cardiovascular risk score
timeFrame: 1 year
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Javad Kojuri
state: Fars
Study officials:
References: