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NCT Number: NCT06311071

The Predictive Value of Coronary Artery Calcium Score

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Javad Kojuri

Shiraz, Fars, 7134814336, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcium score

Diagnostic Test

Calcium score of coronaries obtained fro coronary CT angiography

Other names: CAC score

Invasive coronary angiography

Diagnostic Test

Invasive coronary angiography from radial artery with contrast injection

Primary outcomes

  1. coronary artery disease

    Time frame: 1 year

    stenosis more than 50% in selective coronary angiography

  2. coronary calcium score

    Time frame: 1 year

    calcium score obtained from coronary CT angiography, 0 no risk, 0-100 low risk, more than 100 high risk

Secondary outcomes

  1. cardiovascular risk score

    Time frame: 1 year

    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%

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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