The Predictive Value of Coronary Artery Calcium Score

NCT06311071 | Completed DMC

• 1 other identifier: IR.SUMS.MED.REC.1401.200
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; coronary calcium score; cardiovascular risk score

Outcome Measures

Primary Outcomes (2)

• coronary artery disease

  stenosis more than 50% in selective coronary angiography

  1 year

• 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 Outcomes (1)

• cardiovascular risk score

  1 year

Study Arms (1)

patient group

patient suspected to have coronary artery disease in noninvasive tests

Diagnostic Test: calcium score; Diagnostic Test: Invasive coronary angiography

Interventions

calcium score DIAGNOSTIC_TEST

Calcium score of coronaries obtained fro coronary CT angiography

Also known as: CAC score

patient group

Invasive coronary angiography DIAGNOSTIC_TEST

Invasive coronary angiography from radial artery with contrast injection

patient group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Previously diagnosed coronary artery disease
• Cerebrovascular accident (CVA)
• Peripheral artery disease
• Pregnancy
• Medical instability
• Hypersensitivity to contrast materials
• Having atrial fibrillation

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Javad Kojuri

Shiraz, Fars, 7134814336, Iran

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 365 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)