HDL-C in Cardiac Syndrome X (HIRICS-X)

HDL-Cholesterol is Inversely Related With Inflammation in Cardiac Syndrome X

High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial generation of nitric oxide (NO) and improves endothelial function and arterial vasoreactivity[11]. In several studies, lower HDL-C level was reported to be associated with increased coronary artery disease (CAD) risk[12-14]. HDL-C also has anti- inflammatory and anti-oxidant activities[15,16]. Concerning anti-inflammatory activity, HDL-C inhibits the activation of monocytes/macrophages and neutrophils[17,18] and inhibits the expression of endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and E-selectin[15].

In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory markers in patients with cardiac syndrome X (CSX).

Study Overview

Study Type

Observational

Enrollment (Actual)

710

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

47 years to 58 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CSX was defined as typical chest pain during rest or effort, abnormal test result for exercise ECG and myocardial perfusion scintigraphy, and the presence of angiographically normal epicardial coronary arteries. Control group was selected from volunteers presented to our hospital with the complaint of typical anginal chest pain who had no ischemia on myocardial perfusion scintigraphy or during the treadmill exercise test, had similar risk profile with the patients (diabetes, hypertension, age, gender) and had normal epicardial coronaries at coronary angiography.

Description

Inclusion Criteria:

  • Must be able to get exercise stress test
  • Must be able to have coronary angiography
  • Clinical diagnosis of typical anginaduring rest or effort
  • Abnormal test result for exercise ECG or myocardial perfusion scintigraphy
  • Must have of angiographically normal epicardial coronary arteries

Exclusion Criteria:

  • Patients with valvular heart disease (mitral stenosis and moderate to severe mitral regurgitation
  • Patients with moderate to severe aortic stenosis and regurgitation including mitral annular calcification)
  • Patients with heart failure (left ventricular ejection fraction <50%)
  • Patients with congenital heart disease, cardiomyopathy, left ventricular hypertrophy, right ventricular hypertrophy
  • Patients with cardiac surgery
  • Patients with thyroid disease
  • Patients with anemia
  • Patients with pulmonary diseases
  • Patients with infectious diseases (locally or systemic)

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

Cohorts and Interventions

Group / Cohort
Control Group
Cardiac Syndrome X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL-Cholesterol
Time Frame: 6 MONTHS
HDL-Cholesterol <40 mg/dL(male) / < 50mg/dL(female) ==> low HDL-C
6 MONTHS
Cardiac Syndrome X
Time Frame: 6 months
Patients who have typical anginal chest pain+ischaemic findings at exercise stress test/myocardial scintigraphy + normal epicardial coronaries at coronary angiography ==> Cardiac syndrome X
6 months
Inflammation
Time Frame: 6 months
CRP > 2,98 mg/dL ==> systemic inflammation
6 months

Collaborators and Investigators

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

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

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

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.

Clinical Trials on Heart Diseases

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