Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311071
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-08
Brief Title:
The Predictive Value of Coronary Artery Calcium Score
Sponsor:
Shiraz University of Medical Sciences
Organization:
Shiraz University of Medical Sciences
Study Overview
Official Title:
The Utility of Coronary Artery Calcium Score for the Prediction of Coronary Artery Disease in Patients With Cardiac Symptoms a Diagnostic Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None