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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06311071
Other study ID # IR.SUMS.MED.REC.1401.200
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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