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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01239979
Other study ID # 388417
Secondary ID
Status Completed
Phase N/A
First received November 12, 2010
Last updated December 21, 2010
Start date January 2009
Est. completion date November 2010

Study information

Verified date January 2009
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Observational

Clinical 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 patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date November 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Iran, Islamic Republic of Isfahan Cardiovascular Research Center Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma myeloperoxidase levels 3 month No
Secondary Clinical risk factors 3 month No
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