Coronary Artery DiseaseNCT03075566
Coronary Artery Disease: a Case- Control Study
An observational study of Coronary Artery Disease, run by Nadia Bouzidi, PhD at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Healthy subjects and Patients
- How many people
- 517 participants
- Where
- 1 siteTunisia
- Study dates
- Sep 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 310 patients with Coronary Artery Disease * 207 healthy subjects
Who may be able to join
- Coronary Artery Disease
Who cannot join
- Severe respiratory disease
- Liver disease
- kidney disease
- Inflammatory diseases (infections, autoimmune disorders, malignancy).
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Faculty of Pharmacy
Monastir, Ibn Sina Street, 5000
NADIA BOUZIDI, PhD, 21622987518, nadiabouzidi1@gmail.com
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Healthy subjects, Patients
- Keywords
- coronary artery disease, risk factors, inflammation, biomarkers, atherosclerosis
- Medical subject headings
- Coronary Artery Disease, Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 517 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadia Bouzidi, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadia Bouzidi, PhD, University of Monastir
- Investigators
- Salima Ferchichi, Pr, Study director, University of Monastir, Faculty of Pharmacy of Monastir, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075566
- Sponsor's protocol ID
- 1500170
- Status last verified
- Mar 2017
- First submitted
- 5 Feb 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38017432
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Markers in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03075566
- Acronym / sponsor ID
- 1500170
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, risk factors, inflammation, biomarkers, atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 517 participants (estimated)
- Lead sponsor
- Nadia Bouzidi, PhDUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 310 patients with Coronary Artery Disease * 207 healthy subjects
Key inclusion criteria (1 listed)
- Coronary Artery Disease
Key exclusion criteria (4 listed)
- Severe respiratory disease
- Liver disease
- kidney disease
- Inflammatory diseases (infections, autoimmune disorders, malignancy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy subjects- 207 healthy subjects were donors,(33.2±12.2 years) recruited from the Blood Bank Department of the University Hospital (Mahdia, Tunisia). | Biological | – |
| Patients- 310 subjects with CAD (60.3±11.0 years) were admitted to the Department of Cardiology, University Hospital (Monastir, Tunisia). | Biological | – |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 38017432Bouzidi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salima Ferchichi, Pr study director
University of Monastir, Faculty of Pharmacy of Monastir, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Nadia Bouzidi, PhD at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NADIA BOUZIDI, PhD (21622987518, nadiabouzidi1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical parameters (time frame: 1 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.