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Coronary Artery Disease: a Case- Control Study

Clinical and Biochemical Markers in Coronary Artery Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03075566
Enrollment
517
Registered
2017-03-09
Start date
2014-09-30
Completion date
2017-12-31
Last updated
2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, risk factors, inflammation, biomarkers, atherosclerosis

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.

Interventions

BIOLOGICALHealthy subjects

\- 207 healthy subjects were donors,(33.2±12.2 years) recruited from the Blood Bank Department of the University Hospital (Mahdia, Tunisia).

BIOLOGICALPatients

\- 310 subjects with CAD (60.3±11.0 years) were admitted to the Department of Cardiology, University Hospital (Monastir, Tunisia).

Sponsors

Nadia Bouzidi, PhD
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Coronary Artery Disease

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemical parameters1 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 markers2 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.

Countries

Tunisia

Contacts

Primary ContactNADIA BOUZIDI, PhD
nadiabouzidi1@gmail.com21622987518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026