HDL-C in Cardiac Syndrome X

Cardiovascular Diseases Clinical Trial

— HIRICS-X  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095964
• Other study ID #: BYIEAH-281
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 24, 2014
• Start date: March 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 47 Years to 58 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Angina, Unstable
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Microvascular Angina
• Myocardial Ischaemia
• Myocardial Ischemia
• Unstable Angina

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL-Cholesterol	HDL-Cholesterol <40 mg/dL(male) / < 50mg/dL(female) ==> low HDL-C	6 MONTHS	No
Primary	Cardiac Syndrome X	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	No
Primary	Inflammation	CRP > 2,98 mg/dL ==> systemic inflammation	6 months	No