NCT03075566

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

February 5, 2017

Last Update Submit

March 3, 2017

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaserisk factorsinflammationbiomarkersatherosclerosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Healthy subjectsBIOLOGICAL

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

PatientsBIOLOGICAL

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* 310 patients with Coronary Artery Disease * 207 healthy subjects

You may qualify if:

  • Coronary Artery Disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy

Monastir, Ibn Sina Street, 5000, Tunisia

RECRUITING

Related Publications (1)

  • Bouzidi N, Gamra H. Relationship between serum interleukin-6 levels and severity of coronary artery disease undergoing percutaneous coronary intervention. BMC Cardiovasc Disord. 2023 Nov 28;23(1):586. doi: 10.1186/s12872-023-03570-8.

    PMID: 38017432DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, DNA

MeSH Terms

Conditions

Coronary Artery DiseaseInflammationAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Salima Ferchichi, Pr

    University of Monastir, Faculty of Pharmacy of Monastir, Tunisia

    STUDY DIRECTOR

Central Study Contacts

NADIA BOUZIDI, PhD

CONTACT

21622987518nadiabouzidi1@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bouzidi Nadia, PhD

Study Record Dates

First Submitted

February 5, 2017

First Posted

March 9, 2017

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)