Coronary Artery Disease: a Case- Control Study

March 3, 2017 updated by: Nadia Bouzidi, PhD

Clinical and Biochemical Markers in Coronary Artery Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Ibn Sina Street
      • Monastir, Ibn Sina Street, Tunisia, 5000
        • Recruiting
        • Faculty of pharmacy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • 310 patients with Coronary Artery Disease
  • 207 healthy subjects

Description

Inclusion Criteria:

  • Coronary Artery Disease

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical parameters
Time Frame: 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.
1 Days
Inflammatory markers
Time Frame: 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.
2 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nadia Bouzidi, PhD

Investigators

  • Study Director: Salima Ferchichi, Pr, University of Monastir, Faculty of Pharmacy of Monastir, Tunisia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1500170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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