Coronary Artery Disease: a Case- Control Study

Coronary Artery Disease Clinical Trial

Official title:

Clinical and Biochemical Markers in Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03075566
• Other study ID #: 1500170
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2017
• Last updated: March 3, 2017
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: University of Monastir
• Contact: NADIA BOUZIDI, PhD
• Phone: 21622987518
• Email: nadiabouzidi1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 517
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Coronary Artery Disease

Exclusion Criteria:

• Severe respiratory disease

• Liver disease

• kidney disease

• Inflammatory diseases (infections, autoimmune disorders, malignancy).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Biological:
• Healthy subjects
- 207 healthy subjects were donors,(33.2±12.2 years) recruited from the Blood Bank Department of the University Hospital (Mahdia, Tunisia).
• Patients
- 310 subjects with CAD (60.3±11.0 years) were admitted to the Department of Cardiology, University Hospital (Monastir, Tunisia).

Locations

Country	Name	City	State
Tunisia	Faculty of Pharmacy	Monastir	Ibn Sina Street

Sponsors (1)

Lead Sponsor	Collaborator
Nadia Bouzidi, PhD

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical parameters	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.	1 Days
Primary	Inflammatory markers	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.	2 Days