Coronary Artery Disease: a Case- Control Study

• Conditions: Coronary Artery Disease

• Registration Number: NCT03075566
• Lead Sponsor: Nadia Bouzidi, PhD

Brief Summary

Atherosclerosis is a chronic inflammatory condition, which is associated by the involvement of several pathological events, and alteration in the serum levels of pro- and anti-inflammatory, and lipid markers.

The investigators evaluated the contribution of serum biomarkers levels to the pathogenesis of coronary artery disease, namely their association with risk factors, clinical presentation, extent and severity of atherosclerotic changes accompanying coronary artery disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2017-02-05
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-03
• Last Update Submitted: 2017-03-03
• Study First Posted: 2017-03-09
• Last Update Posted: 2017-03-09
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 517

Inclusion Criteria

• Coronary Artery Disease

Exclusion Criteria

• Severe respiratory disease
• Liver disease
• kidney disease
• Inflammatory diseases (infections, autoimmune disorders, malignancy).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical parameters	1 Days	* Glucose (mmol/l), urae (mmol/l), creatinin (µmol/l), total cholesterol (mmol/l), high density lipoprotein cholesterol, HDL-C (mmol/l), triglycerides (mmol/l), lipoprotein(a) (g/l), apolipoproteins, apo (g/l) were measured only once in each patient at admission, before angiography and in each control group participant using the COBAS INTEGRA 400 chemical analyzer (Roche Diagnostic, Germany).; * Troponin I (ng/ml), creatine kinase (CK) (UI/L), creatine kinase MB Isoenzyme (CK-MB)(UI/L), glutamic-oxaloacetic transaminase (ASAT) (UI/L) were measured using the COBAS INTEGRA 400 chemical analyzer (Roche Diagnostic, Germany). Only one measure was performed for each participant regarding all these parameters.; * Light density lipoprotein cholesterol, LDL-C (mmol/l) was estimated using the Friedewald equation. Only one measure was performed for each participant.; * Values which were out of the confidence range were considered as abnormal values.
Inflammatory markers	2 Days	* Serum Amyloid A (SAA) (mg/l) was measured using the BN Prospec, Siemens.; * High sensitivity C reactive protein, hsCRP (mg/l) was measured using the COBAS INTEGRA 400 chemical analyzer (Roche Diagnostic, Germany).; * Activin A (pg/ml) was quantified at 450nm using a commercially available ELISA kit (AbFrontier, Young In Frontier Co., Ltd, Korea). Only one measure was performed for each participant.; * Interleukin-6 (pg/ml) was measured using a Cobas E601 analyzer (Roche Diagnostics, Germany). Only one measure was performed for each participant.; * Values which were out of the confidence range were considered as abnormal values.

Trial Locations

Locations (1)

Faculty of Pharmacy; 🇹🇳 Monastir, Ibn Sina Street, Tunisia