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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06237244
Other study ID # IR.SUMS.MED.REC.1402.252
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date September 1, 2023

Study information

Verified date February 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 retrospective study from professor Kojuri clinic registry, total number of 1017 patients with first angiography were included and all data were recorded from registry. Insulin resistance was calculated using laboratory data


Description:

This was an analytical cross-sectional retrospective study involving patients with suspected CAD who underwent coronary angiography between December 2018 and May 2023. The information was obtained from patients referred to the outpatient cardiovascular clinic (Professor Kojuri Cardiology Clinic, Shiraz, Iran, www.kojuriclinic.com). Data was extracted from Professor Kojuri Cardiology Clinic database, including patient's information about the clinical history, presence or absence of specific diseases, angiography/angioplasty results, medications, and laboratory values. A total of 14,708 patients who had undergone coronary angiography at least once were examined. After applying exclusion criteria, 1017 eligible cases were selected for data analysis. The following data was recorded for the included patients: demographic data, past medical history (such as DM, hypertension, etc.), systolic and diastolic blood pressure, weight and height, fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and serum creatinine (Cr). Body mass index (BMI) was calculated as weight (Kg) divided by the square of height (m2). Obesity was defined as BMI ≥ 30 Kg/m2. Laboratory values were selected from the time before angiography, and if not available, from the time shortly after the angiography. This helped us find those values which could best represent the metabolic state of patients at the time of angiography, while reducing the confounding effect of statin use.


Recruitment information / eligibility

Status Completed
Enrollment 1017
Est. completion date September 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with age more than 18 years and having undergone coronary angiography Exclusion Criteria: - incomplete data - history of prior coronary angiography or revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)) - serum creatinine > 1.4 mg/dL - history of chronic kidney disease (CKD) - cancer,

Study Design


Intervention

Diagnostic Test:
triglyceride to glucose ratio
Ratio of triglyceride level to glucose
triglycerdie to HDL ratio
Ratio of triglyceride to HDL cholesterol

Locations

Country Name City State
Iran, Islamic Republic of Shiraz University of Medical Sciences 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 insulin resistance index: level of triglyceride to glucose ratio from blood sample correlation of coronary artery disease and triglyceride glucose ratio in blood laboratory tests 3 years
Primary insulin resistance index: Level of triglyceride to HDL ratio from blood sample correlation of coronary artery disease and triglyceride to HDL level ratio in blood laboratory sample 3 years
Secondary metabolic syndrome metabolic syndrome based on criteria of metabolic syndrome 3 years
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