Coronary Artery DiseaseNCT01239979
Plasma Myeloperoxidase Levels in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among patients with stable and unstable CAD patients and control subjects, and correlate with inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine in the… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- Jan 2009to Nov 2010
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects are diagnosed angiographically following chest pain, clinical manifestations or suspected changes on ECG at Isfahan Cardiovascular Research Center in Iran
Who may be able to join
- Stable and unstable patients with angiographically documented coronary artery disease.
- Control subjects without angiographically documented coronary artery disease.
- All subjects Exclusion Criteria:
- Patients with recent (with in 6 month) myocardial infarction or cardiovascular events,
- surgery (with in 3 month),
- cancer and
- infective or inflammatory diseases were not included in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Association Between Myeloperoxidase Levels and Cardiovascular Risk Factors in Patients With Coronary Artery Disease
The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among patients with stable and unstable CAD patients and control subjects, and correlate with inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine in the patients.
Read the detailed description
Elevation of the leukocyte enzyme myeloperoxidase (MPO) in stable coronary artery disease (CAD) patients in contrast to unstable CAD patients is controversial and its relationship with some inflammatory and noninflammatory markers such as oxidized LDL (ox-LDL) and nitric oxide (NO) in the CAD patients has not been evaluated yet. Evaluation of these relationships is the aim of the study.Also the relationships between MPO and some other inflammatory biomarker such as leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine are examined. This study includes 50 stable CAD, 50 unstable CAD patients and 50 controls. Plasma MPO, ox-LDL, leptin, adiponectin, sPLA2 levels are determined using enzyme immunoassay.Homocysteine and 3-nitrotyrosine are measured using HPLC-fluorescence method. Plasma total NO and other risk factors such as lipid profile, hypertension, smoking, diabetes mellitus and familial history of CAD are also determined in the patients. Results are statistically analysed and the association between all markers are assessed.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stable, Unstable , control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma myeloperoxidase levels
Measured: 3 month
Secondary outcomes (1)
Clinical risk factors
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Saedzaaldin Samsamshariat, PhD, Study director, - Clinical Biochemistry Department, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239979
- Sponsor's protocol ID
- 388417
- Status last verified
- Jan 2009
- First submitted
- 12 Nov 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Myeloperoxidase Levels and Cardiovascular Risk Factors in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01239979
- Acronym / sponsor ID
- 388417
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Nov 2010 (estimated)
- 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.
The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among patients with stable and unstable CAD patients and control subjects, and correlate with inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine in the patients.
Detailed description
Elevation of the leukocyte enzyme myeloperoxidase (MPO) in stable coronary artery disease (CAD) patients in contrast to unstable CAD patients is controversial and its relationship with some inflammatory and noninflammatory markers such as oxidized LDL (ox-LDL) and nitric oxide (NO) in the CAD patients has not been evaluated yet. Evaluation of these relationships is the aim of the study.Also the relationships between MPO and some other inflammatory biomarker such as leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine are examined. This study includes 50 stable CAD, 50 unstable CAD patients and 50 controls. Plasma MPO, ox-LDL, leptin, adiponectin, sPLA2 levels are determined using enzyme immunoassay.Homocysteine and 3-nitrotyrosine are measured using HPLC-fluorescence method. Plasma total NO and other risk factors such as lipid profile, hypertension, smoking, diabetes mellitus and familial history of CAD are also determined in the patients. Results are statistically analysed and the association between all markers are assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable, Unstable , control | – | – |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects are diagnosed angiographically following chest pain, clinical manifestations or suspected changes on ECG at Isfahan Cardiovascular Research Center in Iran
Key inclusion criteria (7 listed)
- Stable and unstable patients with angiographically documented coronary artery disease.
- Control subjects without angiographically documented coronary artery disease.
- Patients with recent (with in 6 month) myocardial infarction or cardiovascular events,
- surgery (with in 3 month),
- cancer and
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma myeloperoxidase levels
Time frame: 3 month
1 secondary outcome
Clinical risk factors
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
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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.
Saedzaaldin Samsamshariat, PhD study director
- Clinical Biochemistry Department, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran
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 Isfahan University of Medical Sciences at 1 site in Iran.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 22 Dec 2010. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma myeloperoxidase levels (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2010.