NCT02095964

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
710

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

March 17, 2014

Last Update Submit

March 24, 2014

Conditions

Keywords

cardiac syndrome Xinflammationdyslipidemia

Outcome Measures

Primary Outcomes (3)

  • HDL-Cholesterol

    HDL-Cholesterol \<40 mg/dL(male) / \< 50mg/dL(female) ==\> low HDL-C

    6 MONTHS

  • 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

  • Inflammation

    CRP \> 2,98 mg/dL ==\> systemic inflammation

    6 months

Study Arms (2)

Cardiac Syndrome X

Control Group

Eligibility Criteria

Age47 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesCoronary Artery DiseaseAngina, UnstableMicrovascular AnginaInflammationDyslipidemias

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 26, 2014

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

March 26, 2014

Record last verified: 2014-03